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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Elizabeth Fosberg, B.A. - 10-CBA@ndmp.org

McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs * Cord blood transplant recipients at international transplant centers * Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) * Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Location Contacts
AdventHealth Orlando Orlando, Florida Rushang Patel, MD - (rushang.patel.md@adventhealth.com)
Advocate Lutheran General Hospital Park Ridge, Illinois
All Children's Hospital St. Petersburg, Florida Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu)
Amarillo Blood and Marrow Transplant Program Amarillo, Texas
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Sonali Chaudhury, MD - (schaudhury@luriechildrens.org)
Arkansas Children's Hospital Little Rock, Arkansas Jason Farrar, MD - (JEFarrar@uams.edu)
Avera Transplant Institute Sioux Falls, South Dakota Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org)
Banner MD Anderson Cancer Center Gilbert, Arizona Matthew Ulrickson, MD - (Matthew.Ulrickson@bannerhealth.com)
Beth Israel Deaconess Boston, Massachusetts David Avigan, MD - (davigan@bidmc.harvard.edu)
Cardinal Glennon Children's Medical Center St Louis, Missouri Deepika Bhatla, MD - (dbhatla@slu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Alan Bidgoli, MD - (alan.bidgoli@choa.org)
Children's Hospital Colorado Aurora, Colorado Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU)
Children's Hospital and Research Center of Oakland Oakland, California
Children's Hospital at Montefiore The Bronx, New York Mahvish Rahim, MD - (mrahim@montefiore.org)
Children's Hospital of Los Angeles Los Angeles, California Neena Kapoor, MD - (nkapoor@chla.usc.edu)
Children's Hospital of Michigan Detroit, Michigan Sureyya Savasan, MD - (ssavasan@med.wayne.edu)
Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana Maria Velez, MD - (mvelez@lsuhsc.edu)
Children's Hospital of Orange County (CHOC) Orange, California Rishikesh Chavan, MD - (rishikesh.chavan@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Timothy Olson, MD - (olsont@email.chop.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Paul Szabolcs, MD - (Paul.szabolcs@chp.edu)
Children's Hospital of Wisconsin Milwaukee, Wisconsin David Margolis, MD - (dmargoli@mcw.edu)
Children's Medical Center Dallas Dallas, Texas Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu)
Children's Mercy Hospital and Clinics Kansas City, Missouri Erin Hall, MD - (emhall@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia David Jacobsohn, MD - (dajacobs@childrensnational.org)
Childrens Hospital Medical Center of Akron Akron, Ohio Megan Sampson, MD - (msampson@akronchildrens.org)
Cincinnati Children's Hospital Cincinnati, Ohio Stella Davies, MD - (stella.davies@cchmc.org)
City of Hope Duarte, California Monzr Al Malki, MD - (malmalki@coh.org)
Cleveland Clinic Cleveland, Ohio Claudio Brunstein, MD - (brunstc@ccf.org)
Cohen Children's Medical Center of New York New Hyde, New York Jonathan Fish, MD - (jfish1@nshs.edu)
Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York Monica Bhatia, MD - (mb2476@columbia.edu)
Cook Children's Hospital Fort Worth, Texas Gretchen Eames, MD - (gretchen.eames@cookchildrens.org)
Dana Farber Cancer Institute Boston, Massachusetts Corey Cutler, MD - (cscutler@partners.org)
Duke University Medical Center Durham, North Carolina Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu)
Emory University Hospital Atlanta, Georgia
Florida Center for Pediatric Cellular Therapy Orlando, Florida Susan Kelly, MD - (susan.kelly.md@flhosp.org)
Fred Hutchinson Cancer Research Center Seattle, Washington Ann Dahlberg, MD - (adahlber@fredhutch.org)
Georgia Cancer Center at Augusta University Health Augusta, Georgia Vamsi K Kota, MD - (vkota@augusta.edu)
Greenebaum Cancer Center - University of Maryland Baltimore, Maryland
H Lee Moffitt Cancer Center Tampa, Florida
Hackensack University Medical Center Hackensack, New Jersey Alfred Gillio, MD - (agillio@humed.com)
Helen DeVos Children's Hospital Grand Rapids, Michigan Troy Quigg, MD - (troy.quigg@spectrumhealth.org)
Henry Ford Health System Detroit, Michigan Nalini Janakiraman, MD - (njanaki1@hfhs.org)
Indiana Blood & Marrow Transplantation Beech Grove, Indiana
Indiana University/Riley Hospital for Children Indianapolis, Indiana Jodi Skiles, MD - (jskiles@iupui.edu)
Johns Hopkins Baltimore, Maryland Allen Chen, MD, PhD - (allenchen@jhmi.edu)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii Randal Wada, MD - (randalw@hawaii.edu)
Karmanos Cancer Institute Detroit, Michigan
Levine Children's Hospital Charlotte, North Carolina Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org)
Loma Linda University Cancer Center Loma Linda, California Hisham Abdel-Azim, MD - (habdelazim@llu.edu)
Loyola University Medical Center Maywood, Illinois Patrick Hagen, MD - (patrick.hagen@lumc.edu)
M.D. Anderson Cancer Center Houston, Texas Elizabeth Shpall, MD - (eshpall@mdanderson.org)
Massachusetts General Hospital Lexington, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida
Mayo Clinic Arizona (adults) Phoenix, Arizona
Mayo Clinic Rochester Rochester, Minnesota
Medical City Dallas Dallas, Texas Vikas Bhushan, MD - (vikas.bhushan@usoncology.com)
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina Michelle Hudspeth, MD - (hudspeth@musc.edu)
Memorial Sloan-Kettering Cancer Center New York, New York Ann Jakubowski, MD - (jakubowa@mskcc.org)
Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee
Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com)
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Medical Center - New York New York, New York Alla Keyzner, MD - (alla.keyzner@mssm.edu)
NIH/NCI Bethesda, Maryland
Nationwide Children's Hospital Columbus, Ohio Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org)
Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware Emi Caywood, MD - (ecaywood@nemours.org)
Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida Edward Ziga, MD - (Edward.ziga@nemours.org)
New York Presbyterian Hospital at Cornell New York, New York Tsiporah Shore, MD - (tbs2001@med.cornell.edu)
New York University Langone Medical Center New York, New York Mohammad M Abdul Hay, MD - (maher.abdulhay@nyulangone.org) Antoine Mesidor - (Antoine.Mesidor@nyulangone.org)
Nih/Nhlbi Bethesda, Maryland Richard Childs, MD - (childsr@nih.gov)
Nih/Niaid Bethesda, Maryland Elizabeth Kang, MD - (ekang@niaid.nih.gov)
Niklaus Children's Hospital Miami, Florida Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org)
North Shore University Hospital Manhasset, New York Ruthee L Bayer, MD - (rbayer@nshs.edu)
Northside Hospital Atlanta, Georgia Scott Solomon, MD - (ssolomon@bmtga.com)
Northwestern Memorial Hospital Chicago, Illinois Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu)
Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon Eneida Nemecek, MD - (nemeceke@ohsu.edu)
Orlando Health Arnold Palmer Hospital for Children Orlando, Florida Rikin Shah - (rikin.shah@orlandohealth.com)
Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy Orlando, Florida Yasser Khaled, MD - (yasser.khaled@orlandohealth.com)
Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu)
Phoenix Children's Hospital Phoenix, Arizona Dana Salzberg, MD - (dsalzberg@phoenixchildrens.com)
Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com)
Rady Children's Hospital San Diego San Diego, California Eric Anderson, MD - (eanderson@rchsd.org)
Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu)
Roger Williams Medical Center Providence, Rhode Island
Roswell Park Cancer Institute Buffalo, New York Kanwaldeep Mallhi, MD - (Kanwaldeep.Mallhi@RoswellPark.org)
Rush University Medical Center Chicago, Illinois
Sarah Cannon BMT Program Nashville, Tennessee
Scripps Green Hospital La Jolla, California James R Mason, MD - (mason.james@scrippshealth.org)
Southwest Cancer Treatment & Research Center Lubbock, Texas
Spectrum Health Grand Rapids, Michigan Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org)
St. Jude Childrens Research Hospital Memphis, Tennessee Renee Madden, MD - (renee.madden@stjude.org)
St. Louis University Medical Center St Louis, Missouri
Stanford University Medical Center Palo Alto, California Andrew Rezvani, MD - (arezvani@stanford.edu)
Stony Brook University Hospital Stony Brook, New York Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu)
Strong Memorial Hospital/University of Rochester Rochester, New York Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu)
Sutter Medical Center Sacramento, California Elias Kiwan, MD - (elias.kiwan@sutterhealth.org)
Texas Children's Hospital - Baylor Medical Center Houston, Texas George Carrum, MD - (gcarrum@houstonmethodist.org)
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio Sumithira Vasu, MD - (sumithira.vasu@osumc.edu)
The Children's Hospital of San Antonio San Antonio, Texas Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org)
The Jewish Hospital Cincinnati, Ohio
Tufts Medical Center Boston, Massachusetts Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org)
Tulane Medical Center New Orleans, Louisiana
UCLA Los Angeles, California Gary Schiller, MD - (gschiller@mednet.ucla.edu)
UCSF (adults) San Francisco, California
UCSF (peds) San Francisco, California Sandhya Kharbanda, MD - (sandhya.kharbanda@ucsf.edu)
Univeristy of Mississippi Medical Center Jackson, Mississippi Carter Milner, MD - (capayne@umc.edu)
University Hospitals Case Medical Center Cleveland, Ohio Hillard Lazarus, MD - (hillard.lazarus@case.edu)
University of Alabama at Birmingham Birmingham, Alabama Joseph Chewning, MD - (jchewning@peds.uab.edu)
University of Arizona Medical Center - Tucson Tucson, Arizona Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu)
University of California San Diego La Jolla, California Kaitlyn Dykes, MD - (kcdykes@health.ucsd.edu)
University of Chicago Chicago, Illinois James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu)
University of Colorado Hospital Aurora, Colorado Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu)
University of Florida Shands Medical Center Gainesville, Florida Jordan Milner, MD - (jordan.milner@ufl.edu)
University of Illinois at Chicago Chicago, Illinois Damiano Rondelli, MD - (drond@uic.edu)
University of Iowa Iowa City, Iowa Margarida Silverman, MD - (margarida-silverman@uiowa.edu)
University of Kansas Westwood, Kansas Joseph McGuirk, DO - (jmcguirk@kumc.edu)
University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky Mohamed Hegazi, MD - (mohamed.hegazi@louisville.edu)
University of Massachusetts North Worcester, Massachusetts
University of Miami (adult) Miami, Florida
University of Miami (peds) Miami, Florida Edward Ziga, MD, MPH - (e.ziga@med.miami.edu)
University of Michigan Ann Arbor, Michigan Jessica Yu - (jjxyu@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Phyllis Warkenton, MD - (pwarkent@unmc.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina Anson Snow, MD - (Anson.Snow@unchealth.unc.edu)
University of Oklahoma Health Science Center Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
University of Pennsylvania/Thomas Jefferson Pittsburgh, Pennsylvania Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Alison Sehgal, MD - (sehgalar@upmc.edu)
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Salt Lake City, Utah Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu)
University of Virginia Charlottesville, Virginia Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu)
University of Wisconsin - Madison Madison, Wisconsin Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu)
VA Puget Sound HCS Seattle, Washington
VA Tennessee Valley Healthcare System Nashville, Tennessee
Vanderbilt University Nashville, Tennessee Michael Byrne, MD - (michael.byrne@vumc.org)
Virginia Commonwealth University Richmond, Virginia John McCarty, MD - (jmccarty@vcu.edu)
Wake Forest University Winston-Salem, North Carolina
Washington University St. Louis St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
Washington University/St. Louis Children's Hospital St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
West Penn Hospital Pittsburgh, Pennsylvania Prerna Mewawalla, MD - (pmewawalla26085@direct.ahn.org)
West Virginia University Morgantown, West Virginia Lauren Veltri, MD - (lveltri@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Mitchell Cairo, MD - (mitchell_cairo@nymc.edu)
Yale New Haven Hospital New Haven, Connecticut Aaron Flagg, MD - (aron.flagg@yale.edu)
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas Gilbert Ancira, MD - (gilbert.p.ancira.mil@health.mil)

Project: Every Child for Younger Patients With Cancer (EVERYCHILD)

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Massey, Gita, V.
NCT02402244
HM20006485
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Inclusion Criteria:
* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem * Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority * Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows: * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant) * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant * All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant * The following other benign/borderline conditions: * Mesoblastic nephroma * Teratomas (mature and immature types) * Myeloproliferative diseases including transient myeloproliferative disease * Langerhans cell histiocytosis * Lymphoproliferative diseases * Desmoid tumors * Gonadal stromal cell tumors * Neuroendocrine tumors including pheochromocytoma * Melanocytic tumors, except clearly benign nevi * Ganglioneuromas * Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit * All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Atrium Health Navicent Macon, Georgia Site Public Contact - (andrew.weatherall@atriumhealth.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Brooke Army Medical Center San Antonio, Texas
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Drexel University School of Medicine Philadelphia, Pennsylvania
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health Saint John Hospital Detroit, Michigan
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
Hospital for Sick Children Toronto, Ontario
Hurley Medical Center Flint, Michigan
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Janeway Child Health Centre St. John's, Newfoundland and Labrador Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
Jersey Shore Medical Center Neptune City, New Jersey
Jim Pattison Children's Hospital Saskatoon, Saskatchewan Site Public Contact - (Jessica.Marien@saskhealthauthority.ca)
John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
King Faisal Specialist Hospital and Research Centre Riyadh,
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mattel Children's Hospital UCLA Los Angeles, California
Mayo Clinic in Rochester Rochester, Minnesota
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
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Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
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Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Miami Cancer Institute Miami, Florida
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NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
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Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
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New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Palms West Radiation Therapy Loxahatchee Groves, Florida
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Princess Margaret Hospital for Children Perth, Western Australia
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
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ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
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Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
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Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Francis Children's Hospital Tulsa, Oklahoma
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Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
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Santa Barbara Cottage Hospital Santa Barbara, California
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Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Griffin, Jordyn
NCT03959085
HM20018568
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Inclusion Criteria:
* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol. * APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732. * Patients must be \> 365 days and \< 25 years of age * Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-9.99 years: WBC \>= 50,000/uL * Age 10-24.99 years: Any WBC * Age 1-9.99 years: WBC \< 50,000/uL with one or more of the following: * Testicular leukemia * CNS leukemia (CNS3) * Steroid pretreatment. * Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction. * Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% blasts on a bone marrow (BM) aspirate; * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy; * OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed. * Patient has newly diagnosed B-LLy Murphy stages III or IV. * Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment. * Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted. * Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy. * Direct bilirubin \< 2.0 mg/dL (34 micromoles/L) * Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U/L * Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
* Patients with Down syndrome are not eligible * With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732. * Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy. * Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells. * Patients with acute undifferentiated leukemia (AUL) are not eligible. * For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply: * T-lymphoblastic lymphoma. * Morphologically unclassifiable lymphoma. * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma. * Patients with known Charcot-Marie-Tooth disease. * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype. * Patients requiring radiation at diagnosis. * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.
PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Atrium Health Navicent Macon, Georgia Site Public Contact - (andrew.weatherall@atriumhealth.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
Edwards Comprehensive Cancer Center Huntington, West Virginia
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health Saint John Hospital Detroit, Michigan
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Janeway Child Health Centre St. John's, Newfoundland and Labrador Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
Jersey Shore Medical Center Neptune City, New Jersey
Jim Pattison Children's Hospital Saskatoon, Saskatchewan Site Public Contact - (Jessica.Marien@saskhealthauthority.ca)
John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mattel Children's Hospital UCLA Los Angeles, California
Mayo Clinic in Rochester Rochester, Minnesota
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Miami Cancer Institute Miami, Florida
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Monash Medical Center-Clayton Campus Clayton, Victoria
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Naval Medical Center -San Diego San Diego, California
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Palms West Radiation Therapy Loxahatchee Groves, Florida
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Royal Hobart Hospital Hobart, Tasmania Site Public Contact - (helpdesk@childrensoncologygroup.org)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Francis Children's Hospital Tulsa, Oklahoma
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Santa Barbara Cottage Hospital Santa Barbara, California
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Scott and White Memorial Hospital Temple, Texas
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (clinicalresearch@sutterhealth.org)
T C Thompson Children's Hospital Chattanooga, Tennessee
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Tufts Children's Hospital Boston, Massachusetts
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UMC Cancer Center / UMC Health System Lubbock, Texas
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vannie Cook Children's Clinic McAllen, Texas Site Public Contact - (jrhartl1@txch.org)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wesley Medical Center Wichita, Kansas Site Public Contact - (WesleyResearch@wesleymc.com)
West Virginia University Charleston Division Charleston, West Virginia
West Virginia University Healthcare Morgantown, West Virginia
Women's and Children's Hospital-Adelaide North Adelaide, South Australia Site Public Contact - (cywhs.oncsec@health.sa.gov.au)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Caring and Coping with Cancer (C3) (C3)

Winter, Marcia - mawinter@vcu.edu

Winter, Marcia
14620
HM20014307
Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
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Virginia Commonwealth University Richmond, Virginia Winter, Marcia - (mawinter@vcu.edu)

Expanded Access of Obinutuzumab in a Patient Who Responded to Treatment While on a Clinical Trial

ctrrecruit@vcu.edu

Yazbeck, Victor, Y
14756
HM20015975
drug: Obinutuzumab, Modality: Chemotherapy (nos)
Non-Hodgkin's Lymphoma
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Virginia Commonwealth University Richmond, Virginia

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source (CivaSheet)

Carra Castagnero - ccastagnero@civatechoncology.com

Fields, Emma, C
NCT02843945
HM20010844
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Inclusion Criteria:
* • Subject signed inform consent * Age \> 18 years * Not pregnant or breast feeding * Patient capable of undergoing anesthesia * Patient selected to undergo Whipple procedure or distal pancreatectomy * Patient does not have metastatic disease * Patients will have close margins * No prior radiation therapy to the region for separate cancer * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery) * Chemotherapy was administered for 2-6 cycles with any combination of the following agents: * Gemcitabine + nb-paclitaxel * FOLFIRINOX * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN) * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
Exclusion Criteria:
* Not surgical candidate * Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer * An IRE candidate (IRE is Percutaneous irreversible electroporation) * Recurrent or previously resected tumors * Documented History of Alcoholism and or drug abuse * Participant in other clinical trials
DEVICE: Directional Brachytherapy Source Implant
Pancreatic Cancer
brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation
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Advocate Christ Medical Center Oak Lawn, Illinois Colleen Valenti, OCN - (colleen.valenti@advocatehealth.com)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Rush University Cancer Center Chicago, Illinois
Tampa General Hospital Tampa, Florida Raegen Einsmann - (reinsmann@usf.edu)
University Medical Center LSU New Orleans, Louisiana
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Gowda, Madhu, S
NCT03126916
HM20015351
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Inclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916) * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \>= 365 days and =\< 30 years of age at diagnosis * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible: * Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features: * MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR * Age \> 547 days regardless of biologic features * Patients with INRG stage MS disease with MYCN amplification * Patients with INRG stage L2 disease with MYCN amplification * Patients \> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M * Patients \>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows: * 1 to \< 2 years: male = 0.6; female = 0.6 * 2 to \< 6 years: male = 0.8; female = 0.8 * 6 to \< 10 years: male = 1; female = 1 * 10 to \< 13 years: male = 1.2; female = 1.2 * 13 to \< 16 years: male = 1.5; female = 1.4 * \>= 16 years: male = 1.7; female = 1.4 * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45 * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \> 50% by echocardiogram or radionuclide angiogram * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be \> 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296) * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296) * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296) * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2 * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Exclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial) * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants * FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296) * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial) * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants * PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Busulfan, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dexrazoxane Hydrochloride, BIOLOGICAL: Dinutuximab, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography Test, DRUG: Etoposide Phosphate, RADIATION: External Beam Radiation Therapy, RADIATION: Iobenguane I-123, RADIATION: Iobenguane I-131, DRUG: Isotretinoin, DRUG: Lorlatinib, PROCEDURE: Magnetic Resonance Imaging, DRUG: Melphalan Hydrochloride, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Sargramostim, PROCEDURE: Therapeutic Conventional Surgery, DRUG: Thiotepa, DRUG: Topotecan Hydrochloride, DRUG: Vincristine Sulfate
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
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AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health Saint John Hospital Detroit, Michigan
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Janeway Child Health Centre St. John's, Newfoundland and Labrador Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mattel Children's Hospital UCLA Los Angeles, California
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McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
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Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center -San Diego San Diego, California
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
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Penn State Children's Hospital Hershey, Pennsylvania
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Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
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Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

Daniel J. DeAngelo, MD, PhD - daniel_deangelo@dfci.harvard.edu

Maher, Keri
NCT03150693
HM20015403
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Inclusion Criteria:
REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized * Rating: M0, M1; Blast Cells (%): 0-5.0 * Rating: M2; Blast Cells (%): 5.1-25.0 * Rating: M3; Blast Cells (%): \> 25-50 * Rating: M4; Blast Cells (%): \> 50.0 * The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \>= 750/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \>= 75,000/mm\^3 * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome * RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN) EXCLUSION CRITERIA * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 8 days prior to registration is required * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist
DRUG: Allopurinol, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Vincristine Sulfate, DRUG: Dexamethasone, DRUG: Pegylated L-Asparaginase, DRUG: Methotrexate, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Cyclophosphamide, DRUG: Mercaptopurine, BIOLOGICAL: Rituximab, DRUG: Doxorubicin, DRUG: Thioguanine, BIOLOGICAL: Inotuzumab Ozogamicin, OTHER: Laboratory Biomarker Analysis
B Acute Lymphoblastic Leukemia
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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Advanced Breast Care Center PLLC Warren, Michigan
Alaska Breast Care and Surgery LLC Anchorage, Alaska
Alaska Oncology and Hematology LLC Anchorage, Alaska
Alaska Women's Cancer Care Anchorage, Alaska
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada
American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah
Anchorage Associates in Radiation Medicine Anchorage, Alaska
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Ann M Wierman MD LTD Las Vegas, Nevada
Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta
Ascension Via Christi Hospitals Wichita Wichita, Kansas
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina
Banner North Colorado Medical Center Greeley, Colorado
Banner North Colorado Medical Center - Loveland Campus Loveland, Colorado
Bay Area Hospital Coos Bay, Oregon
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming
Blank Children's Hospital Des Moines, Iowa
Boulder Community Foothills Hospital Boulder, Colorado
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cambridge Medical Center Cambridge, Minnesota
Cancer Center of Colorado at Sloan's Lake Denver, Colorado
Cancer Center of Kansas - Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas
Cancer Center of Western Wisconsin New Richmond, Wisconsin
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Blood Specialists-Henderson Henderson, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
CancerCare Manitoba Winnipeg, Manitoba
Caro Cancer Center Caro, Michigan
Carson Tahoe Regional Medical Center Carson City, Nevada
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Central Care Cancer Center - Bolivar Bolivar, Missouri
Central Care Cancer Center - Garden City Garden City, Kansas
Central Care Cancer Center - Great Bend Great Bend, Kansas
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Cheyenne Regional Medical Center-West Cheyenne, Wyoming
Clackamas Radiation Oncology Center Clackamas, Oregon
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Colorado Blood Cancer Institute Denver, Colorado
Community Cancer Institute Clovis, California
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Medical Center-Lakeside Lubbock, Texas
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Dana-Farber Cancer Institute Boston, Massachusetts
Desert West Surgery Las Vegas, Nevada
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Essentia Health - Deer River Clinic Deer River, Minnesota
Essentia Health - Fosston Fosston, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota
Essentia Health - Park Rapids Park Rapids, Minnesota
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota
Essentia Health Sandstone Sandstone, Minnesota
Essentia Health Virginia Clinic Virginia, Minnesota
Essentia Health-Hayward Clinic Hayward, Wisconsin
Essentia Health-Spooner Clinic Spooner, Wisconsin
Fairbanks Memorial Hospital Fairbanks, Alaska
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota
Fairview Lakes Medical Center Wyoming, Minnesota
Fairview Northland Medical Center Princeton, Minnesota
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota
Freeman Health System Joplin, Missouri
Fresno Cancer Center Fresno, California
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado
Great Falls Clinic Great Falls, Montana
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii
Hawaii Cancer Care Inc-Liliha Honolulu, Hawaii
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri
Hematology Oncology Consultants-Clarkston Clarkston, Michigan
Hennepin County Medical Center Minneapolis, Minnesota
Henry Ford Health Saint John Hospital Detroit, Michigan
Henry Ford Health Warren Hospital Warren, Michigan
Henry Ford Madison Heights Hospital - Breast Warren, Michigan
Henry Ford River District Hospital East China Township, Michigan
Henry Ford Rochester Hospital Rochester Hills, Michigan
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan
Henry Ford Warren Hospital - GLCMS Warren, Michigan
Holy Cross Hospital Fort Lauderdale, Florida
Hope Cancer Care of Nevada Las Vegas, Nevada
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada
Hope Cancer Center Pontiac, Michigan
Hope Cancer Clinic Livonia, Michigan
Houston Methodist Hospital Houston, Texas
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Idaho Urologic Institute-Meridian Meridian, Idaho
Inova Fairfax Hospital Falls Church, Virginia
Inova Schar Cancer Institute Fairfax, Virginia
Intermountain Health Lutheran Hospital Wheat Ridge, Colorado
Intermountain Medical Center Murray, Utah
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Island Urology Honolulu, Hawaii
Island Urology-Hilo Hilo, Hawaii
Jefferson Healthcare Port Townsend, Washington
Jewish General Hospital Montreal, Quebec
Kadlec Clinic Hematology and Oncology Kennewick, Washington
Kaiser Permanente Cancer Treatment Center South San Francisco, California
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, California
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Medical Center-Vacaville Vacaville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii
Kaiser Permanente Oakland-Broadway Oakland, California
Kaiser Permanente Sacramento Medical Center Sacramento, California
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Washington Seattle, Washington
Kaiser Permanente- Marshall Medical Offices Redwood City, California
Kaiser Permanente- Modesto MOB II Modesto, California
Kaiser Permanente-Deer Valley Medical Center Antioch, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California
Kaiser Permanente-Redwood City Redwood City, California
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Rafael San Rafael, California
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Stockton Stockton, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Katmai Oncology Group Anchorage, Alaska
Kingman Regional Medical Center Kingman, Arizona
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kuakini Medical Center Honolulu, Hawaii
LDS Hospital Salt Lake City, Utah
Lake Region Healthcare Corporation-Cancer Care Fergus Falls, Minnesota
Lakeview Hospital Stillwater, Minnesota
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Prostate Cancer Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Green Valley Henderson, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Las Vegas Urology - Sunset Las Vegas, Nevada
Lawrence Memorial Hospital Lawrence, Kansas
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Logan Regional Hospital Logan, Utah
Long Island Jewish Medical Center New Hyde Park, New York
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
Macomb Hematology Oncology PC Warren, Michigan
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Arizona Scottsdale, Arizona
Mayo Clinic in Rochester Rochester, Minnesota
McKay-Dee Hospital Center Ogden, Utah
Medical Center of Baton Rouge Baton Rouge, Louisiana
Medical College of Wisconsin Milwaukee, Wisconsin
Memorial Hospital West Pembroke Pines, Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Methodist West Hospital West Des Moines, Iowa
Miami Cancer Institute Miami, Florida
Michigan Healthcare Professionals Pontiac Pontiac, Michigan
Miller-Dwan Hospital Duluth, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota
Miriam Hospital Providence, Rhode Island
Monticello Cancer Center Monticello, Minnesota
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan
MyMichigan Medical Center Tawas Tawas City, Michigan
NYP/Weill Cornell Medical Center New York, New York
National Jewish Health-Main Campus Denver, Colorado
National Jewish Health-Northern Hematology Oncology Thornton, Colorado
National Jewish Health-Western Hematology Oncology Golden, Colorado
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
New Ulm Medical Center New Ulm, Minnesota
Newland Medical Associates-Clarkston Clarkston, Michigan
Newland Medical Associates-Pontiac Pontiac, Michigan
North Memorial Medical Health Center Robbinsdale, Minnesota
North Shore University Hospital Manhasset, New York
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Wisconsin Cancer Center Ashland, Wisconsin
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Anthony's Health Center Alton, Illinois
Ochsner Health Center-Summa Baton Rouge, Louisiana
Ochsner High Grove Baton Rouge, Louisiana
Ochsner Medical Center Jefferson New Orleans, Louisiana
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Oncology Las Vegas - Henderson Henderson, Nevada
Oncology Las Vegas - Tenaya Las Vegas, Nevada
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Orlando Health Cancer Institute Orlando, Florida Site Public Contact - (CancerClinicalTrials@orlandohealth.com)
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Overlake Medical Center Bellevue, Washington
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A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Griffin, Jordyn
NCT04293562
HM20020887
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Bone marrow and/or blood must have been submitted to the BPC via APEC14B1 for testing of FLT3 markers. Patients without samples submitted for FLT3 testing are not eligible * Patients must be at least 6 months of age and less than 22 years of age at the time of study enrollment * Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease * Patient must have 1 of the following: * \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment) * In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy * \< 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment) * A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell \[WBC\] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy is pending or cannot be performed (performed within 7 days prior to enrollment) * ARM C: Patient must be \>= 2 years of age at the time of Late Callback * ARM C: Patient must have FLT3/ITD allelic ratio \> 0.1 as reported by Molecular Oncology * ARM C: Patient does not have any congenital long QT syndrome or congenital heart block * ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib * ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib * ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib * ARM D: Patient must be \>= 2 years of age at the time of Late Callback * ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine * ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib * ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib * ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib * NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible * NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment * NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking * NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation) * NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Fanconi anemia * Shwachman Diamond syndrome * Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 * Telomere disorders * Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy * Any concurrent malignancy * Juvenile myelomonocytic leukemia (JMML) * Philadelphia chromosome positive AML * Mixed phenotype acute leukemia * Acute promyelocytic leukemia * Acute myeloid leukemia arising from myelodysplasia * Therapy-related myeloid neoplasms * Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) \< 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \< 24%. \*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen * Administration of prior anti-cancer therapy except as outlined below: * Hydroxyurea * All-trans retinoic acid (ATRA) * Corticosteroids (any route) * Intrathecal therapy given at diagnosis * In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment * Patients \< 8.3 kg at study enrollment are not eligible * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation * ARM D: Patient does not have any congenital long QT syndrome or congenital heart block
PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexrazoxane Hydrochloride, DRUG: Etoposide, OTHER: Fludeoxyglucose F-18, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib Fumarate, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, DRUG: Mitoxantrone Hydrochloride, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, DRUG: Therapeutic Hydrocortisone
Acute Myeloid Leukemia
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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health Saint John Hospital Detroit, Michigan
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Jersey Shore Medical Center Neptune City, New Jersey
Jim Pattison Children's Hospital Saskatoon, Saskatchewan Site Public Contact - (Jessica.Marien@saskhealthauthority.ca)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mattel Children's Hospital UCLA Los Angeles, California
Mayo Clinic in Rochester Rochester, Minnesota
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Palms West Radiation Therapy Loxahatchee Groves, Florida
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia
Phoenix Childrens Hospital Phoenix, Arizona
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Santa Barbara Cottage Hospital Santa Barbara, California
Scott and White Memorial Hospital Temple, Texas
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada
Sydney Children's Hospital Randwick, New South Wales
T C Thompson Children's Hospital Chattanooga, Tennessee
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Tufts Children's Hospital Boston, Massachusetts
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Virginia University Charleston Division Charleston, West Virginia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Gowda, Madhu, S
NCT00736749
HM12659
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Inclusion Criteria:
* The patient must reside in the U.S. on the date of enrollment to ALTE05N1 * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Assessment of Therapy Complications, OTHER: Questionnaire Administration
Hematopoietic Cell Transplantation Recipient, Leukemia, Solid Tumor
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Study Locations

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Location Contacts
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (dperry@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas Site Public Contact - (helpdesk@childrensoncologygroup.org)
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (melissa.leffin@orlandohealth.com)
Ascension Saint John Hospital Detroit, Michigan Site Public Contact - (stephanie.couch@stjoeshealth.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (helpdesk@childrensoncologygroup.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (helpdesk@childrensoncologygroup.org)
Broward Health Medical Center Fort Lauderdale, Florida
C S Mott Children's Hospital Ann Arbor, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars Sinai Medical Center Los Angeles, California
Children's Healthcare of Atlanta - Egleston Atlanta, Georgia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital Los Angeles Los Angeles, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital Medical Center Of Akron Akron, Ohio Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital New Orleans New Orleans, Louisiana Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (helpdesk@childrensoncologygroup.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (CancerAnswer@ccf.org)
Columbia Regional Columbia, Missouri Site Public Contact - (helpdesk@childrensoncologygroup.org)
Connecticut Children's Medical Center Hartford, Connecticut Site Public Contact - (helpdesk@childrensoncologygroup.org)
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (helpdesk@childrensoncologygroup.org)
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio Site Public Contact - (helpdesk@childrensoncologygroup.org)
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (helpdesk@childrensoncologygroup.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (helpdesk@childrensoncologygroup.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts
Florida Hospital Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Greenville Cancer Treatment Center Greenville, South Carolina
Hackensack University Medical Center Hackensack, New Jersey
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Inova Fairfax Hospital Falls Church, Virginia
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Lee Memorial Health System Fort Myers, Florida
Legacy Emanuel Children's Hospital Portland, Oregon Site Public Contact - (helpdesk@childrensoncologygroup.org)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Lurie Children's Hospital-Chicago Chicago, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (mamcdci@amedd.army.mil)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (helpdesk@childrensoncologygroup.org)
Mattel Children's Hospital UCLA Los Angeles, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Mayo Clinic Rochester, Minnesota
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Mercy Children's Hospital Toledo, Ohio
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas
Miami Cancer Institute Miami, Florida Site Public Contact - (cancerinfo@baptisthealth.net)
Miller Children's and Women's Hospital Long Beach Long Beach, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Mission Hospital Inc-Memorial Campus Asheville, North Carolina Site Public Contact - (leslie.verner@msj.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (aaraiza@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (nr2616@cumc.columbia.edu)
NYU Winthrop Hospital Mineola, New York
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (helpdesk@childrensoncologygroup.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Nemours Children's Clinic - Orlando Orlando, Florida
Nemours Children's Clinic - Pensacola Pensacola, Florida
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey
Norton Children's Hospital Louisville, Kentucky
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (nnechiporchik@novanthealth.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Gregory.Johnstone@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Overlook Hospital Summit, New Jersey
Penn State Children's Hospital Hershey, Pennsylvania Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Primary Children's Hospital Salt Lake City, Utah Site Public Contact - (helpdesk@childrensoncologygroup.org)
Prisma Health Richland Hospital Columbia, South Carolina
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (helpdesk@childrensoncologygroup.org)
Rady Children's Hospital - San Diego San Diego, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (helpdesk@childrensoncologygroup.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania Site Public Contact - (helpdesk@childrensoncologygroup.org)
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (helpdesk@childrensoncologygroup.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Luke's Mountain States Tumor Institute Boise, Idaho Site Public Contact - (helpdesk@childrensoncologygroup.org)
Saint Mary's Hospital West Palm Beach, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (helpdesk@childrensoncologygroup.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (Christy.Gilchrist@hshs.org)
Saint Vincent Hospital and Health Care Center Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
San Jorge Children's Hospital San Juan,
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington Site Public Contact - (helpdesk@childrensoncologygroup.org)
Sinai Hospital of Baltimore Baltimore, Maryland Site Public Contact - (pridgely@lifebridgehealth.org)
Southern Illinois University School of Medicine Springfield, Illinois
St. Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (helpdesk@childrensoncologygroup.org)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
T C Thompson Children's Hospital Chattanooga, Tennessee
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio
The University of Arizona Medical Center-University Campus Tucson, Arizona
Tulane University Health Sciences Center New Orleans, Louisiana
UCSF Medical Center-Mission Bay San Francisco, California
UCSF Medical Center-Parnassus San Francisco, California
UF Cancer Center at Orlando Health Orlando, Florida
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Florida Health Science Center - Gainesville Gainesville, Florida
University of Hawaii Cancer Center Honolulu, Hawaii
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota Site Public Contact - (helpdesk@childrensoncologygroup.org)
University of Mississippi Medical Center Jackson, Mississippi
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (LByatt@nmcca.org)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Wisconsin Hospital and Clinics Madison, Wisconsin
Valley Children's Hospital Madera, California Site Public Contact - (helpdesk@childrensoncologygroup.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Site Public Contact - (mwellons@vcu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Site Public Contact - (ctoadmin@karmanos.org)
West Virginia University Charleston Division Charleston, West Virginia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (INDICATE)

Loney, Shenise - loneys2@vcu.edu

Urdaneta, Alfredo, I
NCT04423211
HM20021980
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Inclusion Criteria:
* STEP 0: REGISTRATION ELIGIBILITY CRITERIA * Patient must be male and \>= 18 years of age. * Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma * Patient must have biochemical recurrence (BCR) after RP, defined as follows: * If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible) * If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required * If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement * Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration * Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration * Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT) * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT. * Patient must not be enrolled in another therapeutic clinical trial * Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery * Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI * Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration * Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy * Hemoglobin (Hgb) \>= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration) * Leukocytes \>= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration) * Absolute neutrophil count \>= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration) * Platelets \>= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration) * Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, must have a direct bilirubin of \< 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration) * Creatine \< 1.5 x instituional ULN (or measured creatinine clearance \> 30 mL/min) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment) * Patient must not have completed a course of prior pelvic radiation therapy for any reason * Patient must agree not to father children while on study * Patient must be English or Spanish speaking to be eligible for the QOL component of the study * NOTE: Sites cannot translate the associated QOL forms * STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA * Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration * For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative) * For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \[prostate bed +/- typical whole pelvis\]), the number of extra-pelvic lesions must be known (1 - 5 or \> 5 extra-pelvic lesions)
RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Apalutamide, PROCEDURE: Computed Tomography, DRUG: Degarelix, RADIATION: External Beam Radiation Therapy, OTHER: Fluciclovine F18, DRUG: Goserelin Acetate, PROCEDURE: Intensity-Modulated Proton Therapy, RADIATION: Intensity-Modulated Radiation Therapy, DRUG: Leuprolide Acetate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Relugolix, RADIATION: Stereotactic Body Radiation Therapy, DRUG: Triptorelin, RADIATION: Volume Modulated Arc Therapy
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska
Alegent Health Lakeside Hospital Omaha, Nebraska
Alton Memorial Hospital Alton, Illinois
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care-Wausau Wausau, Wisconsin
Audie L Murphy VA Hospital San Antonio, Texas
BASS Medical Group - Lennon Walnut Creek, California
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Northwest - Spokane South Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-North Spokane Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
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Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
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Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
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Cooper Hospital University Medical Center Camden, New Jersey
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Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania
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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Gwaltney, Lindsey - lbgwaltney@vcu.edu

Boomer, Laura, A
NCT05235165
HM20024392
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment. * Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size. * Note: Patient must have eligibility confirmed by rapid central imaging review. * Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon. * Patients must have a histological diagnosis of osteosarcoma. * Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease. * Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery. * Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation. * Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor. * Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi). * Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion. * Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team. * Patients with evidence of extrapulmonary metastatic disease. * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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Location Contacts
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Ann M Wierman MD LTD Las Vegas, Nevada
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
C S Mott Children's Hospital Ann Arbor, Michigan
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital at Montefiore The Bronx, New York Site Public Contact - (aaraiza@montefiore.org)
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
King Faisal Specialist Hospital and Research Centre Riyadh,
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Green Valley Henderson, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Las Vegas Urology - Sunset Las Vegas, Nevada
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Nicklaus Children's Hospital Miami, Florida
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
Northern Nevada Radiation Oncology Reno, Nevada
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Radiation Oncology Associates Reno, Nevada
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Royal Children's Hospital Parkville, Victoria
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Michigan Rogel Cancer Center Ann Arbor, Michigan Site Public Contact - (CancerAnswerLine@med.umich.edu)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

Marco Carini, Prof. - carini@unifi.it

NCT05363657
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Inclusion Criteria:

• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
• Age ?18 years
• Informed consent signed
Exclusion Criteria:

• Patient refuse to participate in clinical research.
• Urothelial renal carcinoma.
Procedure: Partial Nephrectomy (PN), Procedure: Radical Nephrectomy (RN), Procedure: Ablation therapy (AT), Diagnostic Test: Active Surveillance (AS)
Kidney Cancer
Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
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Show 37 locations

Study Locations

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Location Contacts
AOUI Verona Verona, Vr Alessandro Antonelli - (alessandro.antonelli@me.com)
Amsterdam University Medical Centers Amsterdam, Axel Bex - (a.bex@nki.nl)
Azienda Ospedaliera Policlinico "G. Martino", Universit? di Messina. Messina, Vincenzo Ficarra - (vficarra@unime.it)
Bristol Urological Institute Bristol, Francis Keeley - (Francis.Keeley@nbt.nhs.uk)
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital Firenze, Andrea Mari - (andrea.mari@unifi.it)
Division of Urology, University of Genoa,Policlinico San Martino Hospital Genova, Carlo Terrone - (carlo.terrone@med.uniupo.it)
European Health Center Otwock, Lukasz Nyk - (ukinyk@poczta.fm) Hubert Kamecki - (hubert@kamecki.pl)
Fundaci? Puigvert Barcelona, Joan Palou - (ipalou@fundacio-puigvert.es)
Guy's Hospital London, Ben Challacombe - (benchallacombe@doctors.org.uk)
Hospital Universitario Ram?n y Cajal, University of Alcal Madrid, Vital Hevia - (vital.hevia.uro@gmail.com)
Humanitas Hospital Rozzano, Nicolomaria Buffi - (nicolo.buffi@hunimed.eu)
Institute Oncology Veneto (IOV) Padova, Angelo Porreca - (angeloporreca@gmail.com)
Institute of Urology, University of Southern California. Los Angeles, California Giovanni E Cacciamani - (giovanni.cacciamani@med.usc.edu)
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale" Napoli, Sisto Perdona' - (s.perdona@istitutotumori.na.it)
Jikei University School of Medicine Minato-ku, Tokyo, Shin Egawa - (s-egpro@jikei.ac.jp)
Loyola University Medical Center, Edward Hines VA Hospital Chicago, Illinois Gopal Gupta - (GOGUPTA@lumc.edu)
Medical University of Vienna, Vienna General Hospital Vienna, Shahkrokh F Shariat - (shahrokh.shariat@meduniwien.ac.at)
N.N. Blokhin National Medical Research Center of Oncology Moscow, Vsevolod Matveev - (vsevolodmatveev@mail.ru)
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Warsaw, Roman Sosnowski - (roman.sosnowski@gmail.com)
Ng Teng Fong General Hospital Singapore, Vineet Gaauhaar - (vineetgaauhaar@gmail.com)
Onze Lieve Vrouw Hospital Leuven, Geert De Naeyer - (geertdenaeyer@yahoo.com)
Policlinico Istituto Europeo di Oncologia (IEO) Milano, Ottavio De Cobelli - (Ottavio.DeCobelli@ieo.it)
Policlinico Riuniti, Universit? di Foggia. Foggia, Giuseppe Carrieri - (giuseppe.carrieri@unifg.it) Gian Maria Busetto - (gianmaria.busetto@unifg.it)
Policlinico S. Orsola Malpighi Bologna, Riccardo Schiavina - (rschiavina@yahoo.it)
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital Milano, Umberto Capitanio - (umbertocapitanio@gmail.com)
Santa Casa da Miseric?rdia de Fortaleza Fortaleza, Francisco Hidelbrando A Mota Filho - (fha.motafilho@gmail.com)
Stanford University Stanford, California Benjamin I Chung - (bichung@stanford.edu)
Swedish Hospital Seattle, Washington James Porter - (porter@swedishurology.com)
Universit? degli Studi di Torino, Ospedale S. Luigi Gonzaga. Torino, Francesco Porpiglia - (porpiglia@libero.it)
Universit? degli studi di Torino, Ospedale Molinette Torino, Paolo Gontero - (paolo.gontero@unito.it)
University Hospitals Leuven Leuven, Maarten Albersen - (maarten.albersen@uzleuven.be)
University of Bruxelles Bruxelles, Simone Albisinni - (albisinni.simone@gmail.com)
University of California San Diego, Moores Cancer Center San Diego, California Ithaar Derweesh - (iderweesh@gmail.com)
University of Patras Patras, Evangelos Liatsikos - (liatsikos@yahoo.com)
University of Pennsylvania Philadelphia, Pennsylvania Philip Pierorazio - (Phillip.Pierorazio@pennmedicine.upenn.edu)
Urology, Andrology & Kidney Transplantation Unit, University of Bari Bari, Pasquale Ditonno - (pasquale.ditonno@uniba.it)
VCU Health System Richmond, Virginia Riccardo Autorino - (ricautor@gmail.com)

Longitudinal Cohort Registry of Cancer Survivors

Hong, Susan - susan.hong@vcuhealth.org

Hong, Susan
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
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Virginia Commonwealth University Richmond, Virginia Hong, Susan - (susan.hong@vcuhealth.org)

Multiplex Analysis of Venetoclax Sensitivity in Patients Diagnosed with AML or CLL

Lantis, Kristin - kllantis@vcu.edu

Grant, Steven
17581
HM20020962
Myeloid and Monocytic Leukemia, Lymphoid Leukemia
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Virginia Commonwealth University Richmond, Virginia Lantis, Kristin - (kllantis@vcu.edu)

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

ctrrecruit@vcu.edu

NCT04726241
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Inclusion Criteria:
* Patients must be less than 22 years of age at the time of study enrollment * Patient must have one of the following at the time of study enrollment: * Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol * This includes isolated myeloid sarcoma * Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS) * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria: * Second or greater B-ALL medullary relapse, excluding KMT2Ar * Any first or greater B-ALL medullary relapse involving KMT2Ar * Any first or greater T-ALL medullary relapse with or without KMT2Ar * Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
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Show 184 locations

Study Locations

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Location Contacts
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Cleveland Clinic Foundation Cleveland, Ohio
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
HIMA San Pablo Oncologic Hospital Caguas,
Hackensack University Medical Center Hackensack, New Jersey
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Jersey Shore Medical Center Neptune City, New Jersey
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Nicklaus Children's Hospital Miami, Florida
Northwestern Medicine Central DuPage Hospital Winfield, Illinois Site Public Contact - (Claudine.Gamster@CadenceHealth.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Phoenix Childrens Hospital Phoenix, Arizona
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UMC Cancer Center / UMC Health System Lubbock, Texas
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USA Health Strada Patient Care Center Mobile, Alabama
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Missouri Children's Hospital Columbia, Missouri Site Public Contact - (snwq62@health.missouri.edu)
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Kenneth B. De Santes - (kbdesantes@pediatrics.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC)

Sarin Chhab - schhab@gog.org

NCT04831580
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Inclusion Criteria:

• Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
• Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
• Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
• Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard and agree to be randomized to undergo open or robotic radical (or simple) hysterectomy. NOTE: Simple hysterectomy will be allowed in patients who meet the following criteria:
• pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
• less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been performed. Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomization for review and confirmation of simple hysterectomy being met (see Section 6.0 for instructions).
• Patient must be age 18 years or older.
• Patient must have ECOG performance status 0-1.
• Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
• Patient must have signed an approved informed consent and authorization permitting the release of personal health information.
Exclusion Criteria:

• Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation)
• Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
• Patient with inability to receive an MRI.
• Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).
• Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
• Patients with a history of prior pelvic or abdominal radiotherapy.
• Patients with a prior malignancy \< 5 years from enrollment with the exception of non-melanoma skin cancer.
• Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
• Patient compliance and geographic proximity that do not allow adequate follow-up.
• Patients with poorly controlled HIV with CD4 counts \<500.
DEVICE: da Vinci, OTHER: open surgery
Cervical Cancer
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Show 156 locations

Study Locations

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Location Contacts
A.C.Camargo Cancer Center São Paulo, São Paulo Daniela Augustin - (daniela.augustin@lacogcancerresearch.org)
AHN West Penn Hospital Pittsburgh, Pennsylvania - (janke.mainsmason@ahn.org)
Abington Memorial Hospital Abington, Pennsylvania Ashley Douglas - (ashley.douglas@jefferson.edu)
Alliance Cancer Specialists, PC Wynnewood, Pennsylvania Mark Shahin, MD - (mark.shahin@usoncology.com)
Asan Medical Center Seoul, Seoul Teukbyeolsi Dae Yeon Kim, MD - (kdyog@amc.seoul.kr)
Ascension Medical Group St. Vincent's Obstetrics and Gynecology Jacksonville, Florida Nicole Antenucci - (nicole.antenucci@ascension.org)
Asplundh Cancer Pavillion Willow Grove, Pennsylvania Ashley Douglas - (ashley.douglas@jefferson.edu)
Baptist Health Lexington, Kentucky Lauren Higgins - (lauren.higgins@bhsi.com)
Baptist Health Lexington Lexington, Kentucky Lauren Higgins - (lauren.higgins@bhsi.com)
Barretos Cancer Hospital Barretos, São Paulo Daniela Augustin - (daniela.augustin@lacogcancerresearch.org)
Baystate Medical Center Springfield, Massachusetts
Brazilian National Cancer Institute Rio de Janeiro, Gustavo Guitmann, PhD - (Guitmann@clinicagincol.com.br)
CHA Bundang Medical Center Gyeonggi-do, Hyun Park, MD - (p06162006@cha.ac.kr)
California Pacific Medical Center-Research Institute San Francisco, California
Center of Hope Reno, Nevada Shannon White Pierpoint - (spierpoint@cohreno.com)
Centre Hospitalier de l'Université de Montréal Montreal, Mathilde Duplaix - (mathilde.duplaix.chum@ssss.gouv.qc.ca)
Chattanooga's Program in Women's Oncology Chattanooga, Tennessee Kimberly Donelson - (Kimberly.Donelson@erlanger.org)
City of Hope Duarte, California Raechelle Tinsley - (RTinsley@coh.org)
City of Hope - Upland Upland, California Raechelle Tinsley - (rtinsley@coh.org)
City of Hope Orange County Lennar Foundation Cancer Irvine, California Raechelle Tinsley - (rtinsley@coh.org)
David C. Pratt Center St Louis, Missouri Crystal Tindall - (crystal.tindall@mercy.net)
Duke Cancer Center Durham, North Carolina Taylor Hayes - (taylor.hayes@duke.edu)
Duke Cancer Center Durham, North Carolina Lauren March - (lauren.march@duke.edu)
Duke University Hospital Durham, North Carolina Taylor Hayes - (taylor.hayes@duke.edu)
FirstHealth Outpatient Cancer Center Pinehurst, North Carolina
Gangnam Severance Hospital Seoul, JaeHoon Kim - (jaehoonkim@yuhs.ac) HyunJin Lee - (pistis@yuhs.ac)
Georgian Cancer Center at Augusta University Augusta, Georgia Angela Goebel - (agoebel@augusta.edu)
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut New Britain, Connecticut Siobhan Reilly - (mailto:siobhan.reilly@hhchealth.org)
Hartford Healthcare Cancer Institute at Hartford Hospital Hartford, Connecticut Siobhan Reilly - (mailto:siobhan.reilly@hhchealth.org)
Hartford Healthcare Medical Group-Manchester Manchester, Connecticut Siobhan Reilly - (mailto:siobhan.reilly@hhchealth.org)
Hartford Hospital Hartford, Connecticut Siobhan Reilly - (mailto:siobhan.reilly@hhchealth.org)
Hoag Gynecologic Oncology Newport Beach, California Ana Navarrete - (ana.navarrete@hoag.org)
Hoag Memorial Hospital Presbyterian Newport Beach, California Ana Navarrete - (ana.navarrete@hoag.org)
Hospital Erasto Gaertner Curitiba, Erik M Coelho - (erik.coelho@lacog.group) Audrey Tsunoda, MD - (atsunoda@gmail.com)
Hospital Municipal Vila Santa Catarina São Paulo, Sao Paula Renato Moretti-Marques, MD - (renato.moretti@einstein.br)
Hospital de Base - Fundacao Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, São Paulo Carlos E Andrade, MD - (mdcarlosandrade@gmail.com) Erik Coelho - (erik.coelho@lacog.group)
Inova Health System Fairfax, Virginia Takada Harris - (takada.harris@inova.org)
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio Callan Myercough - (callan.myerscough@osumc.edu)
JamesCare Gynecologic Oncology at Mill Run Hilliard, Ohio Callan Myerscough - (macallan.myerscough@osumc.edu)
Josie Robertson Surgery Center New York, New York Josie Anderson - (andersj@mskcc.org)
Kettering Health Cancer Center Kettering, Ohio Julie Carstens - (julie.carstens@ketteringhealth.org)
Korea University Anam Hospital Seongbuk-Gu, Jae-Yun Song, MD - (sjyuni105@gmail.com)
Korea University Guro Hospital Seoul, Guro-gu Sohyeon Jeong, MD - (shj9918@gmail.com)
LSU Health New Orleans New Orleans, Louisiana Dina Brackman - (dbrack@lsuhsc.edu)
Laura and Issac Perlmutter Cancer Center at NYU Langone New York, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
Laura and Issac Perlmutter Cancer Center at NYU Langone New York, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street New York, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
Legacy Good Samaritan Medical Center-Gynecological Oncology Group Portland, Oregon
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology Tualatin, Oregon
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology Vancouver, Washington
M Health Fairview University of Minnesota Medical Center-East Bank Hospital Minneapolis, Minnesota Erin Zielinksi - (eezielin@umn.edu)
M Health Fairview University of Minnesota Medical Center-East Bank Hospital Minneapolis, Minnesota Erin Zielinksi - (eezielin@umn.edu)
Magee - Womens Hospital of UPMC Pittsburgh, Pennsylvania Jessica Yauch - (yauchj@upmc.edu)
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology Scarborough, Maine Robin Donovan - (donovr@mmc.org)
McGill University Health Centre-Glen Site Montreal, Quebec Phuong-Nam Nguyen - (mailto:phuong-nam.nguyen@mail.mcgill.ca)
Memorial Sloan Kettering (Basking Ridge) Basking Ridge, New Jersey Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering (Bergen) Montvale, New Jersey Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering (Commack) Commack, New York Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering (Monmouth) Middletown, New York Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering (Nassau) Uniondale, New York Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering (Westchester) Harrison, New York Josie Anderson - (andersj@mskcc.org)
Memorial Sloan Kettering Cancer Center (Main Campus) New York, New York Josie Anderson - (mailto:andersj@mskcc.org)
Mercy Hospital Coon Rapids, Minnesota Jennifer Mosley - (Jennifer.mosley@hcahealthcare.com)
Mercy Hospital Coon Rapids, Minnesota Jennifer Mosley - (Jennifer.mosley@hcahealthcare.com)
Miami Cancer Institute at Baptist Health, Inc. Miami, Florida Jacqueline Lebron - (jacquelile@baptisthealth.net)
Miami Cancer Institute at Baptist Health, Inc. Miami, Florida Stephany Fuentes Angulo - (Stephany.FuentesAngulo@baptisthealth.net)
Minnesota Oncology Hematology Minneapolis, Minnesota Jessica Thomes-Pepin - (jessica.thomespepin@usoncology.com)
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida
NHPP/Gynecologic Oncology at New Hyde Park New Hyde Park, New York Batool Mubashar - (mailto:bmubashar@northwell.edu)
NYU Langone Ambulatory Care Bay Ridge Brooklyn, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
NYU Langone Hospital-Brooklym Brooklyn, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
NYU Langone Medical Center (Tisch Hospital) New York, New York Kathryn Allen - (mailto:Kathryn.Allen@nyulangone.org)
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters Brightwaters, New York Batool Mubashar - (mailto:bmubashar@northwell.edu)
Northwell Health/Huntington Hospital Huntington, New York Batool Mubashar - (mailto:bmubashar@northwell.edu)
Northwell Health/Long Island Jewish Medical Center New Hyde Park, New York Batool Mubashar - (mailto:bmubashar@northwell.edu)
Northwell Health/South Shore University Hospital Bay Shore, New York Batool Mubashar - (mailto:bmubashar@northwell.edu)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
Novant Health Cancer Institute Charlotte, North Carolina - (kashah@novanthealth.org)
OSU Wexner Medical Center Hospital East Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Martha Morehouse Outpatient Care Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care Dublin Dublin, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care East Columbus, Ohio Callan Myserscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care Gahanna Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care Lewis Center Lewis Center, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care New Albany Westerville, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Outpatient Care Upper Arlington Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
OSU Wexner Medical Center University Hospital Columbus, Ohio Callan Myerscough - (callan.myerscough@osumc.edu)
Orlando Health Cancer Center Orlando, Florida
Orlando Health Winnie Palmer Hospital for Woman and Babies Orlando, Florida
Palo Alto Medical Foundation Palo Alto, California
Princess Margaret Cancer Center Toronto, Ontario Vanessa Ballin - (Vanessa.Ballin@uhn.ca) Sarah Ferguson, MD - (sarah.ferguson@uhn.ca)
Providence Center Institute Franz Clinic Portland, Oregon Nora Auston - (Nora.Auston@providence.org)
Samsung Medical Center Seoul, Chel Hun Choi, PhD - (chelhun.choi@samsung.com)
Seoul National University Bundang Hospital Seongnam, Dong Hoon Suh, MD - (sdhwcj@naver.com)
Seoul St. Mary's Hospital - Catholic University Seoul, Sung Jong Lee, MD - (orlando@catholic.ac.kr)
Severance Hospital - Yonsei Cancer Center Seoul, Ji Won, Woo - (te05028@yuhs.ac) Sang-wun Kim, MD, PhD - (san1@yuhs.ac)
Severance Hospital - Yonsei Cancer Center Seoul, Sangwun Kim, MD - (san1@yuhs.ac)
South Miami Hospital Miami, Florida Jacqueline Lebron - (jacquelile@baptisthealth.net)
South Miami Hospital Miami, Florida Stephany Fuentes Angulo - (Stephany.FuentesAngulo@baptisthealth.net)
Southeastern Regional Medical Center LLC Newnan, Georgia
St. Elizabeth Healthcare Edgewood, Kentucky
St. Vincent Hospital and Health Care Center Inc Indianapolis, Indiana
St. Vincent Hospital and Health Care Center, Inc Indianapolis, Indiana
Stanford Hospital Stanford, California Samya Konda - (skonda@stanford.edu)
Stephenson Cancer Center Oklahoma City, Oklahoma Morgan Hays - (mailto:morgan-hays@ouhsc.edu)
Summa Health Jean and Milton Copper Pavilion Akron, Ohio Danielle McCutcheon - (mccutcheond@summahealth.org)
Summa Health Jean and Milton Copper Pavillion Akron, Ohio Danielle McCutcheon - (mamccutcheond@summahealth.org)
Tampa General Hospital Tampa, Florida
Texas Oncology San Antonio, Texas Nori Sullivan - (mailto:nori.sullivan@usoncology.com)
Texas Oncology- Baylor Charles A. Sammons Cancer Center Dallas, Texas Christine Terraciano - (christine.terraciano@usoncology.com)
Texas Oncology- GYN ONC DFWW Bedford, Texas Nori Sullivan - (mailto:nori.sullivan@usoncology.com)
Texas Oncology-Austin Austin, Texas Kelli Watkins - (kelli.watkins@mckesson.com)
Texas Oncology-DFWW Bedford, Texas Sarah Wade - (mailto:Sarah.Wade@usoncology.com)
Texas Oncology-GYN ONC DFWW Fort Worth, Texas Nori Sullivan - (mailto:nori.sullivan@usoncology.com)
Texas Oncology-San Antonio San Antonio, Texas Riquanda Walker - (Riquanda.Walker@McKesson.com)
Texas Oncology-The Woodlands, Gynecologic Oncology The Woodlands, Texas Kelli Watkins - (Kelli.Watkins@mckesson.com)
The Blavatnik Family - Chelsea Medical Center at Mount Sinai New York, New York Neha Kumarley - (Kuneha.kumarley@mssm.edu)
The West Clinic, PLLC dba West Cancer Center Germantown, Tennessee Joslyn Walker - (jowalker@westclinic.com)
TriHealth Cancer Institute-Good Samaritan Hospital Cincinnati, Ohio
TriHealth Cancer Institute-Thomas Comprehensive Care Center Cincinnati, Ohio
UCLA Gynecologic Oncology Clinic Los Angeles, California Dana Chase, MD - (dmchase@mednet.ucla.edu)
University of California San Diego Medical Center San Diego, California - (aocronin@health.ucsd.edu)
University of California San Diego Medical Center San Diego, California - (aocronin@health.ucsd.edu)
University of California San Diego Medical Center San Diego, California - (aocronin@health.ucsd.edu)
University of California San Diego Medical Center San Diego, California - (aocronin@health.ucsd.edu)
University of California San Diego Moores Cancer Center La Jolla, California - (aocronin@health.ucsd.edu)
University of Cleveland Medical Center Cleveland, Ohio Lauren Patrick - (Lauren.Patrick@uhhospitals.org)
University of New Mexico Comprehensive Cancer Center Albuquerque, New Mexico
University of Pennsylvania Health System, Perelman Center for Advanced Medicine Philadelphia, Pennsylvania Christine Yang - (christine.yang@pennmedicine.upenn.edu)
University of Texas Southwestern Medical Center Dallas, Texas Annette Paulsen - (mailto:Annette.Paulsen@UTSouthwestern.edu)
University of Texas Southwestern Medical Center-Simmons Cancer Center Dallas, Texas Annette Paulsen - (mailto:Annette.Paulsen@UTSouthwestern.edu)
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital Dallas, Texas Annette Paulsen - (Annette.Paulsen@UTSouthwestern.edu)
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital Dallas, Texas Annette Paulsen - (Annette.Paulsen@UTSouthwestern.edu)
University of Virginia Charlottesville, Virginia Rachel Lacy - (rmc9p@hscmail.mcc.virginia.edu)
University of Virginia Comprehensive Cancer Center Charlottesville, Virginia Rachel Lacy - (mrmc9p@hscmail.mcc.virginia.edu)
University of Wisconsin Clinical Science Center Madison, Wisconsin Claire Kostechka - (kostechka@wisc.edu)
VCU Health Emergency Center at New Kent Quinton, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
VCU Health Short Pump Pavillion Richmond, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
VCU Health at GreenGate Henrico, Virginia Sonya Washington - (slwashington@vcu.edu)
VCU Health at Tappahannock Hospital Tappahannock, Virginia
VCU Health-William and Mary Williamsburg, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
Virginia Commonwealth University-Main Hospital Richmond, Virginia Sonya Washington - (mailto:slwashington@vcu.edu)
West Virginia Morgantown, West Virginia Christina Martinelli - (mailto:christina.martinelli@hsc.wvu.edu)
West Virginia University Morgantown, West Virginia Christina Martinelli - (mailto:christina.martinelli@hsc.wvu.edu)
Western Regional Medical Center LLC Goodyear, Arizona
Willis-Knighton Physician Network Gynecologic Oncology Associates Shreveport, Louisiana Carrie Key, RN - (ckay@wkhs.com)
Women's and Infants Hospital of Rhode Island Program in Women's Oncology Providence, Rhode Island Ann John - (ajohn@wihri.org)

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

ctrrecruit@vcu.edu

NCT05136196
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Inclusion Criteria:
* STEP 1 - SPECIMEN SUBMISSION * Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible * Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration * Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration * Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable * Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration * Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration * Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above) * Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management * Participants must have recovered to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy * Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria: * If the primary radiation is combined with chemotherapy, a minimum of 16 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration. If the radiation is given alone, a minimum of 8 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration * Additional palliative radiotherapy regimens are permitted but cannot have been administered to previously treated tissue (i.e., overlapping fields are excluded) with the exception of central nervous system (CNS) radiation and must be completed at least 4 weeks prior to step 1 registration * Treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation * Participants must not have received prior treatment with anti-VEGF therapies for any reason * Participants must be \>= 18 years of age * Participants must have a Zubrod Performance Status 0 or 1 * Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better to be eligible for this trial * Participants must not have any known significant organ disfunction that, in the opinion of the treating investigator, may impact suitability for receiving combination nivolumab/cabozantinib treatment * Participants must be able to take oral medication without breaking, opening, crushing, dissolving or chewing capsules * Participants must not have malabsorption syndrome * Participants must not have active autoimmune disease requiring systemic steroids (equivalent of \> 10mg of prednisone) or other immune suppression. Exceptions: * Type 1 diabetes mellitus * Endocrinopathy only requiring hormone replacement * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment * Conditions not expected to recur in the absence of an external trigger * Participants must not have received an organ allograft * Participants must not have a history of hemoptysis (defined as \>= 1/2 tsp of bright red blood per day) or tumor bleeding within 90 days prior to step 1 registration * Participants must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with cabozantinib therapy: * Prior carotid bleeding * Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies * Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies * Any prior history of bleeding related to the current head and neck cancer * History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months * Participants must not require concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel) * Participants must not require anticoagulants except for the following: * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to step 1 registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor * Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to step 1 registration as documented by baseline blood pressure reading with systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing due to the known safety profiles of the drugs in this study. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential". In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and vasectomy with testing showing no sperm in the semen * Have an adequate archival tissue specimen verified by the local pathologist and documented on the Pathology Review Form from a procedure obtained after the development of resistance to anti-PD-1/L1 therapy. Archival tissue must consist of tumor block or at least 1 hematoxylin and eosin (H\&E)-stained 4-5 micron slide and 20 freshly cut serially sectioned and numbered 4-5 micron unstained, uncharged slides OR Be willing to undergo research biopsy AND have tumor accessible for biopsy based on the following criteria: * Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be obtained incidentally to a clinically necessary procedure and NOT for the sole purpose of the clinical trial * Acceptable biopsy procedures are: * Percutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications \< 2% * Direct transoral biopsy (with or without local anesthetic and/or sedation) with an expected risk of severe complications \< 2% * Excisional cutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications \< 2% * Biopsy with removal of additional tumor tissue during a medically necessary mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or craniotomy. No open surgical, laparoscopic or endoscopic procedure should be performed solely to obtain a biopsy for this protocol * Removal of additional tumor tissue during a medically necessary surgical procedure * Participants must submit whole blood for germline genomic analysis * Participants must have been offered the opportunity to participate in specimen banking * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) * STEP 2 TREATMENT REGISTRATION * Note: No tests or exams are required to be repeated for step 2 registration (Treatment). However, participants who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration * Participants must continue to meet eligibility for step 1 registration prior to step 2 registration * Participants must have had their tumor tissue submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration * Participants registered during stage II of the protocol must have received assignment to an open cohort from the SWOG Statistics and Data Management Center based on their biomarker screening profile (not applicable for patients registered during stage I of the protocol) * Participants must have measurable disease. All measurable disease must be assessed within 28 days prior to step 2 registration. All non-measurable disease must be assessed within 42 days prior to step 2 registration. Note: All disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) * For melanoma participants, CT chest, abdomen and pelvis must be obtained. For HNSCC participants, CT neck and chest must be obtained. Further imaging (i.e., MR brain, CT abdomen/pelvis or extremities, bone scan) will be performed as deemed appropriate by the treating physician * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy * Participants must not have experienced any significant health changes that, in the opinion of the treating investigator, may impact continued suitability for receiving combination nivolumab/cabozantinib treatment * Participants with treated brain metastases must have discontinued steroid treatment at least 14 days prior to step 2 registration * Participants must not have received investigational agents or monoclonal antibodies (except Food and Drug Administration \[FDA\] approved supportive care antibodies, such as denosumab) within 28 days prior to step 2 registration * Participants must not have received surgery, chemotherapy, radiation therapy, biologic agents, or steroids within 14 days prior to step 2 registration * Participants must not have received administration of a live, attenuated vaccine within 30 days prior to step 2 registration. Note: Participants may have received a messenger ribonucleic acid (mRNA) or viral vector-based coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to step 2 registration * Participants must not have received administration of any strong CYP3A4 inducers, such as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort, within 14 days prior to step 2 registration * Participants must not have received administration of any strong CYP3A4 inhibitors, such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin, within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration * Participants must have a history and physical examination performed within 28 days prior to step 2 registration * Leukocytes \>= 3,000/uL (within 28 days prior to step 2 registration) * Absolute neutrophil count \>= 1,500/uL (within 28 days prior to step 2 registration) * Platelets \>= 100,000/uL (within 28 days prior to step 2 registration) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) or =\< 3 x ULN for participants with Gilbert's disease (within 28 days prior to step 2 registration) * Aspartate aminotransferase (AST) =\< 3 x institutional ULN (within 28 days prior to step 2 registration) * Alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to step 2 registration) * Urinalysis: For baseline value (no required value for eligibility) * Measured (OR calculated) creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 registration
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Cabozantinib S-malate, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma, Locally Recurrent Laryngeal Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oropharyngeal Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Melanoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Melanoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Unresectable Melanoma
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (protocols@swog.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia Site Public Contact - (Kevin.Patel@centrahealth.com)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dartmouth Cancer Center - North Saint Johnsbury, Vermont Site Public Contact - (cancer.research.nurse@hitchcock.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Inova Alexandria Hospital Alexandria, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Fair Oaks Hospital Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Jefferson Torresdale Hospital Philadelphia, Pennsylvania
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
Loyola University Medical Center Maywood, Illinois
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Mercy Cancer Center-West Lakes Clive, Iowa
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Medical Center - Des Moines Des Moines, Iowa
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Chaska Chaska, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (WI_research_admin@hshs.org)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Medical Center Honolulu, Hawaii
Rapid City Regional Hospital Rapid City, South Dakota Site Public Contact - (research@monument.health)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rocky Mountain Regional VA Medical Center Aurora, Colorado
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Charles Health System Bend, Oregon Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Southeastern Medical Oncology Center-Clinton Clinton, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California Site Public Contact - (protocols@swog.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
Tower Cancer Research Foundation Beverly Hills, California Site Public Contact - (towercancerresearch@toweroncology.com)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Muskegon Hospital Muskegon, Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Tufts Medical Center Boston, Massachusetts
Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCHealth Greeley Hospital Greeley, Colorado Site Public Contact - (protocols@swog.org)
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
USC / Norris Comprehensive Cancer Center Los Angeles, California
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United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Unity Hospital Fridley, Minnesota
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of Illinois Chicago, Illinois
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University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
VCU Health Tappahannock Hospital Tappahannock, Virginia Site Public Contact - (klcampbell@vcu.edu)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Virginia Cancer Institute Richmond, Virginia Site Public Contact - (smoore@vacancer.com)
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan
Weisberg Cancer Treatment Center Farmington Hills, Michigan
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)

Comprehensive Tobacco Cessation for Cancer Patients and Survivors

Antonice Wall - walla2@vcu.edu

NCT05805722
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Inclusion Criteria:
* Provision of signed and dated informed consent form * Stated willingness to comply with study procedures and availability for the duration of the study * Have a documented history of cancer of any type, whether active or in remission * Identify as a current or recently-quit tobacco user
Exclusion Criteria:
* Not a VCUHealth patient * Non English-speaking
BEHAVIORAL: Behavioral counseling for tobacco cessation
Tobacco Use Cessation, Cancer
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Virginia Commonwealth University Richmond, Virginia Massey CPC Team - (masseycpc@vcu.edu)

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (cAMeLot-1)

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT04811560
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Inclusion Criteria:
Phase 1: * Age 2 years to less than (\<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above * Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options * Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations Phase: 2 * Participants greater than 18 years are eligible * Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease * AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only For Both Phase 1 and 2: * Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count \<= 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate \>= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants \< 16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age) * A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment * Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria * Active central nervous system (CNS) disease * Prior solid organ transplantation * QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded * Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement) * Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
DRUG: Bleximenib
Acute Leukemia
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Asan Medical Center Seoul, Seoul Teukbyeolsi
Baylor University Medical Center Dallas, Texas
CHRU Nancy Brabois Vandœuvre-lès-Nancy,
CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy,
CHU Bretonneau Tours,
CHU Lyon Sud Pierre-Bénite,
CHU de Nantes hotel Dieu Nantes,
Carmel Medical Center Haifa,
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac,
China Medical University Hospital Taichung,
City of Hope Duarte, California
Clinica Univ. de Navarra Pamplona,
Dana Farber Cancer Institute Boston, Massachusetts
First Affiliated Hospital Medical School of Zhejiang University Hangzhou,
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fukushima Medical University Hospital Fukushima,
Fundacao Antonio Prudente A C Camargo Cancer Center São Paulo,
Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo São Paulo,
Ghent University Hospital Ghent,
Gold Coast University Hospital Southport,
Gunmaken Saiseikai Maebashi Hospital Maebashi,
Gustave Roussy Villejuif, Val-de-marne
Guys and St Thomas NHS Foundation Trust London,
Hadassah University Hospita Ein Kerem Jerusalem,
Henan Cancer Hospital Zhengzhou, Henan
Hokkaido University Hospital Hokkaido, Sapporo,
Hopital Jean Minjoz Besançon,
Hopital Maisonneuve Rosemont Montreal, Quebec
Hopital Saint Louis Paris,
Hopital trousseau- APHP Paris,
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre Strasbourg,
Hosp Clinic de Barcelona Barcelona,
Hosp Clinico Univ de Salamanca Salamanca,
Hosp Univ Fund Jimenez Diaz Madrid,
Hosp Univ Vall D Hebron Barcelona,
Hosp. Clinico Univ. de Valencia Valencia,
Hosp. Gral. Univ. Gregorio Marañon Madrid,
Hosp. Virgen Del Rocio Seville,
Hospital Infantil Universitario Nino Jesus Madrid,
Houston Methodist Hospital Houston, Texas
IDOR - Regional Brasilia Brasília,
IDOR - Regional Sao Paulo São Paulo,
Institut Paoli Calmettes Marseille,
Institut Universitaire du Cancer Toulouse Oncopole Toulouse,
Institute of Hematology and Blood Diseases Hospital Tianjin,
Kanazawa University Hospital Ishikawa, Kanazawa,
Karmanos Cancer Institute Detroit, Michigan
Kobe City Medical Center General Hospital Kobe,
Kyushu University Hospital Fukuoka,
Leeds Teaching Hospitals NHS Trust Leeds,
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
MD Anderson Houston, Texas
Maine Health Providence, Rhode Island
Massachusetts General Hospital Lexington, Massachusetts
Medical College of WI at Froedtert Milwaukee, Wisconsin
Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro,
Monash Medical Centre Clayton, Victoria
Montefiore Medical Center The Bronx, New York
NTT Medical Center Tokyo Tokyo,
NYU Langone Medical Center New York, New York
Nagoya University Hospital Aichi, Nagoya,
Nanfang Hospital of Southern Medical Hospital Guangzhou,
National Cancer Center Hospital East Kashiwa, Chiba
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Norton Cancer Institute Louisville, Kentucky
Oregon Health and Science University Portland, Oregon
Oxford University Hospitals NHS Trust Oxfordshire,
Peking University First Hospital Beijing,
Princess Margaret Cancer Centre University Health Network Toronto, Ontario
Qilu Hospital of Shandong University Jinan, Shandong
Roswell Park Comprehensive Cancer Center Buffalo, New York
Royal Perth Hospital Perth, Western Australia
START Midwest Grand Rapids, Michigan
Samsung Medical Center Seoul,
San Antonio Methodist TX Transplant Physicians Group San Antonio, Texas
Seoul National University Hospital Seoul,
Sheba Medical Center Ramat Gan,
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis, Indiana
Swedish Cancer Institute Seattle, Washington
Tel Aviv Sourasky Medical Center Tel Aviv,
The Christie NHS Foundation Trust Manchester, Lancashire
The Clatterbridge Cancer Centre Liverpool,
The First Affiliated Hospital of NanChang University Nanchang,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
UCSF Benioff Children's Hospital San Francisco, California
Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan,
University College London Hospitals London,
University Hospital of Wales Cardiff,
University Hospitals Plymouth NHS Trust Plymouth,
University of California Irvine Medical Center Orange, California
University of California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Fukui Hospital Yoshida,
University of New Mexico Albuquerque, New Mexico
University of Tennessee Medical Center Knoxville, Tennessee
Vancouver Coastal Health Vancouver, British Columbia
Virginia Commonwealth University Richmond, Virginia
West China Hospital Si Chuan University Chengdu,
Yamagata University Hospital Yamagata, Yamagata
Zhongda Hospital Southeast University Nanjing,
the First Hospital of Jilin University Changchun, Jilin

Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

ctrrecruit@vcu.edu

NCT03606967
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiologic suspicion of metastatic TNBC can be consented prior to this confirmation. * Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor. * HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+. * PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions. * Patients may have measurable or evaluable disease. * Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed primary, metastatic, or locally advanced sites of disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ, unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. * No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy. * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%). * Body weight \> 30 kg. * Must have a life expectancy of at least 12 weeks. * Absolute neutrophil count \>= 1,500/mcL. * Platelets \>= 100,000/mcL. * Hemoglobin \>= 9.0 g/dL. * Serum bilirubin =\< 1.5 x institutional upper limit of normal. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x institutional upper limit of normal. * Calculated creatinine clearance \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \> 250, and are on a stable antiretroviral regimen. * Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver/guardian.
Exclusion Criteria:
* Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible. * Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study. * Patients who have received prior immunotherapy for metastatic disease. * Patients who have not recovered from grade \>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. * Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. * Patients with grade \>= 2 endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study, and the endocrinological AE must be stable in the opinion of the treating physician. * Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days. * Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab. * Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment. * Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection) * Systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid * Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication) * Steroids for symptoms from brain metastases as defined. * Spinal cord compression or active brain metastases and/or carcinomatous meningitis. Subjects who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to registration are eligible if they meet all of the following criteria: * Residual neurological symptoms have resolved to grade =\< 2 * On stable doses of dexamethasone, if applicable and if acceptable in the opinion of the treating physician * Follow-up MRI performed after surgery or completion of radiation therapy and prior to registration shows no new lesions. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 \[+/- 3\] minutes apart). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * History of pneumonitis or interstitial lung disease. * History of active primary immunodeficiency. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). * The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: * Patient has undergone potentially curative therapy for all prior malignancies. * Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix). * Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered. * History of allogeneic organ transplantation.
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Gemcitabine Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, BIOLOGICAL: Personalized Synthetic Long Peptide Vaccine, DRUG: Poly ICLC, BIOLOGICAL: Sacituzumab Govitecan, BIOLOGICAL: Tremelimumab
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
NYP/Weill Cornell Medical Center New York, New York
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California
UCHealth University of Colorado Hospital Aurora, Colorado
UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
University of Texas Medical Branch Galveston, Texas Site Public Contact - (clinical.research@utmb.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Wake Forest University at Clemmons Clemmons, North Carolina
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Yale University New Haven, Connecticut

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Iovance Biotherapeutics https://www.tilvance-301.com - Clinical.Inquiries@iovance.com

NCT05727904
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Inclusion Criteria:

• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants must have adequate organ function.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:

• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant received more than 1 prior line of therapy.
• Participant received prior therapy for metastatic disease
• Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant. Other protocol defined inclusion/exclusion criteria could apply.
BIOLOGICAL: Lifileucel plus Pembrolizumab, BIOLOGICAL: Pembrolizumab with Optional Crossover Period
Metastatic Melanoma, Unresectable Melanoma, Melanoma
Tumor Infiltrating Lymphocytes, TIL, Metastatic Melanoma, Unresectable Melanoma, Cell Therapy, Cellular Immuno-therapy, IL-2, Non-myeloablative lymphodepletion (NMALD), Check point inhibitor, Melanoma, Lifileucel, Stage III Melanoma, Stage IV Melanoma, Skin cancer, Skin cancer types, Malignant melanoma, Autologous Adoptive Cell Therapy, Autologous Adoptive Cell Transfer, LN-144, Pembrolizumab, Pembro, Adjuvant/Neo-adjuvant, BRAF/MEK, ICI, BRAF v600, Immune checkpoint inhibitor, Tumor infiltrating T-cells, TILVANCE, TILVANCE-301
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Study Locations

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Location Contacts
Allegheny Health Network Pittsburgh, Pennsylvania
Azienda Ospedaliera Universitaria Senese Siena, Si
Azienda Ospedaliero Universitaria Pisana Pisa, Tuscany
Baptist Cancer Center Southaven, Mississippi
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Detroit, Michigan
Beaston West of Scotland Canter Centre Glasgow,
Bundang Medical Center - CHA University Seongnam-si, Gyeonggi-do
California Pacific Medical Center San Francisco, California
Centre Hospitalier Universitaire Vaudois Lausanne Lausanne,
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes,
Centre Hospitalier de l'Université de Montréal Montreal,
Centro di Riferimento Oncologico IRCCS Aviano, Friuli Venezia Giulia
Charite - Universitatsmedizin Berlin Berlin,
City of Hope Duarte, California
Clinica Universitaria de Navarra Pamplona,
Consorcio Hospital General Universitario de Valencia Valencia,
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center Lebanon, New Hampshire
Fiona Stanley Hospital Murdoch, Western Australia
Flinders Medical Centre Bedford Park, South Australia
Freeman Hospital High Heaton,
Greenslopes Private Hospital Greenslopes, Queensland
Guy's Hospital London,
HM Centro Integral Oncológico Clara Campal Madrid, Spain
Hadassah Medical Center Jerusalem, Jerusalem
Helsinki University Hospital Comprehensive Cancer Center Helsinki, Finland
Henry Ford Health Detroit, Michigan
Hopital Saint Louis Paris,
Hospital 12 de Octubre Madrid,
Hospital Clinic de Barcelona Barcelona,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Regional Universitario de Malaga - Hospital General Málaga, Málaga
Hospital Universitari Vall dHebron Barcelona,
Hospital Universitario Madrid Sanchinarro - CIOCC Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen Macarena Seville, Sevilla
ICO l'Hospitalet - Hospital Duran i Reynals Barcelona,
Institut Català d'Oncologia (ICO) Barcelona, Spain
Institut Paoli Calmettes Marseille,
Instituto Oncologico Rosell Barcelona,
Intermountain Health Salt Lake City, Utah
Istituto Europeo Di Oncologia Milan,
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Naples, Napoli
Istituto Romagnolo per lo Studio dei Tumori Meldola, Forli Cesena
Klinikum rechts der Isar der Technischen Universitat Munchen München,
Korea University Anam Hospital Seongbuk-Gu,
MD Anderson Cancer Center at Cooper Camden, New Jersey
National Cancer Centre Singapore Singapore,
National Cancer Institute Bratislava,
Nederlands Kanker Instituut Amsterdam,
Ohio State University Columbus, Ohio
Oncology Hematology Care Cincinnati, Ohio
Orlando Health Cancer Institute Orlando, Florida
Peter MacCallum Cancer Centre Melbourne,
Princess Margaret Cancer Centre Toronto, Ontario
Queen Elizabeth Hospital Birmingham Birmingham,
Royal Marsden Hospital London,
SCRI Oncology Partners Nashville, Tennessee
Sahlgrenska Universitetssjukhuset Gothenburg, Västra Götalands LÄN [se-14]
Samsung Medical Center Seoul,
Sarah Cannon Research Institute UK London, London, CITY of
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Sheba Medical Center Ramat Gan,
St. Luke's Cancer Center - Anderson Easton, Pennsylvania
Swedish Cancer Institute Seattle, Washington
Tel Aviv Sourasky Medical Center Tel Aviv,
USC Norris Comprehensive Cancer Center Los Angeles, California
Universitair Ziekenhuis Brussel - Oncologisch Centrum Jette,
Universitatsklinikum Hamburg-Eppendorf Hamburg,
University of Alabama at Birmingham: The Kirklin Clinic Birmingham, Alabama
University of Colorado Cancer Center Aurora, Colorado
University of Illinois Hospital & Health Sciences System Chicago, Illinois
University of Kansas Westwood, Kansas
University of Louisville - James Graham Brown Cancer Center Louisville, Kentucky
University of Minnesota Minneapolis, Minnesota
Universitätsklinikum Carl Gustav Carus Dresden,
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck,
Universitätsklinikum Würzburg Würzburg,
Virginia Commonwealth University Richmond, Virginia
Westmead Hospital Northmead, New South Wales

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

ctrrecruit@vcu.edu

NCT06317649
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Inclusion Criteria:
* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology * Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11 * Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) \< 25,000/mm\^3 prior to starting venetoclax treatment * Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors * Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol * Patient must be assigned to this protocol by the MYELOMATCH Protocol * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization) * Creatinine clearance ≥ 30 mL/min (must be obtained ≤ 14 days prior to randomization) * Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits: * History of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR * Known genetic predisposition to long QT syndrome OR * Risk for electrolyte abnormalities, including tumor lysis syndrome * Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards * NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (\> 450 ms for males and \> 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better * Patient must not have an uncontrolled infection
DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax
Acute Myeloid Leukemia
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Study Locations

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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Allegiance Health Jackson, Michigan
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Ben Taub General Hospital Houston, Texas
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooperman Barnabas Medical Center Livingston, New Jersey
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Edward Hines Jr VA Hospital Hines, Illinois
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fred Hutchinson Cancer Center Seattle, Washington
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Henry Ford Hospital Detroit, Michigan
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan
Henry Ford Medical Center-Columbus Novi, Michigan
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, California
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente- Modesto MOB II Modesto, California
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California
Kaiser Permanente-Modesto Modesto, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lahey Clinic Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Clinic Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Miami Cancer Institute Miami, Florida
Mid Coast Hospital Brunswick, Maine Site Public Contact - (ctsucontact@westat.com)
Mills Health Center San Mateo, California
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
North Shore University Hospital Manhasset, New York
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OptumCare Cancer Care at Charleston Las Vegas, Nevada
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Pali Momi Medical Center ‘Aiea, Hawaii
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rhode Island Hospital Providence, Rhode Island
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
San Juan City Hospital San Juan,
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Straub Clinic and Hospital Honolulu, Hawaii
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The Valley Hospital - Luckow Pavilion Paramus, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Toll Free Number - Trialsites@msd.com

NCT03486873
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Inclusion Criteria:
* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready. * Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase. Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587: * Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Demonstrates adequate organ function. * Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention. * A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity. Additional eligibility criteria for participants who enter dosing with Lenvatinib: * Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications. * For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib. * Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.
Exclusion Criteria:
-There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies: * Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients. * Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible. * Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment. * Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease. * Has hepatic decompensation (Child-Pugh score \>6 \[class B and C\]). * Has uncontrolled thyroid dysfunction. * Has uncontrolled diabetes mellitus. * Has had an allogeneic tissue/solid organ transplant. * Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Additional exclusion criteria for participants who enter dosing with Lenvatinib: * Has had major surgery within 3 weeks prior to first dose of study intervention(s). * Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. * Has urine protein ≥1 g/24 hours. * Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO). * Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. * Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms. * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. * Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. * Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.
DRUG: Pembrolizumab, DRUG: Standard of Care (SOC), DRUG: Lenvatinib, DRUG: Olaparib, DRUG: MK-4280, BIOLOGICAL: MK-4280A, BIOLOGICAL: Pembrolizumab (+) Berahyaluronidase alfa
Solid Tumors, Hematologic Malignancies
PD1, PD-1, PDL1, PD-L1
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Show 782 locations

Study Locations

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Location Contacts
A. C. Camargo Cancer Center ( Site 1002) São Paulo,
AO Santa Maria della Misericordia-Oncology Department ( Site 1971) Perugia, Umbria
AZ Maria Middelares ( Site 2908) Ghent, Oost-Vlaanderen
AZ Sint-Maarten ( Site 2904) Mechelen, Antwerpen
Aberdeen Royal Infirmary-Department of Oncology ( Site 0521) Aberdeen, Aberdeen City
Acibadem Adana Hospital-Pediatric Hematology-Oncology ( Site 1312) Adana,
Acibadem Altunizade Hospital-Oncology ( Site 1317) Üsküdar /Istanbul, Istanbul
Acibadem Universitesi Atakent Hastanesi ( Site 1319) Istanbul,
Acıbadem Maslak Hastanesi-Medical Oncology ( Site 1321) Istanbul,
Ad-Vance Medical Research-Research ( Site 1151) Ponce,
Adana Sehir Egitim ve Arastirma Hastanesi ( Site 1324) Adana,
Addenbrookes Hospital ( Site 0522) Cambridge, Cambridgeshire
Administradora Country SA - Clinica del Country ( Site 2701) Bogotá, Bogota D.C.
Aichi Cancer Center ( Site 3101) Nagoya, Aichi-ken
Ajou University Hospital ( Site 0969) Suwon, Kyonggi-do
Akdeniz Universitesi Hastanesi-Medical Onkology ( Site 1318) Antalya,
Almazov National Medical Research Centre ( Site 1233) Saint Petersburg, Sankt-Peterburg
Altai Regional Clinical Oncology Center ( Site 1229) Barnaul, Altayskiy Kray
Ambroise Pare Hopital ( Site 2503) Boulogne, Hauts-de-Seine
Amsterdam UMC, locatie VUmc ( Site 1555) Amsterdam, North Holland
Andreas Syggros Hospital ( Site 1853) Athens, Attica
Anhui Provincial Hospital ( Site 3480) Hefei, Anhui
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 3487) Hefei, Anhui
Ankara City Hospital-Medical Oncology ( Site 1311) Ankara,
Ankara University Health Practice and Research Hospitals ( Site 1331) Ankara,
Ankara University Hospital Cebeci ( Site 1306) Ankara,
Antoni van Leeuwenhoek Ziekenhuis ( Site 1551) Amsterdam, North Holland
Arizona Cancer Center at UMC North ( Site 0018) Tucson, Arizona
Arke Estudios Clinicos ( Site 1117) Mexico City, Mexico City
Army Medical Center of People's Liberation Army-Oncology Department ( Site 3477) Chongqing, Chongqing Municipality
Arthur J.E. Child Comprehensive Cancer Centre ( Site 2815) Calgary, Alberta
Asan Medical Center ( Site 0952) Songpagu, Seoul
Asklepion Medical Center ( Site 3667) Khodosovka, Kyivska Oblast
Atatürk Üniversitesi ( Site 1333) Erzurum,
Auckland City Hospital ( Site 1503) Auckland,
Augusta University ( Site 0077) Augusta, Georgia
Austin Health-Austin Hospital ( Site 3004) Heidelberg, Victoria
Avix Investigación Clinica, S.C.-Oncology ( Site 1104) Monterrey, Nuevo León
Azienda Ospedaliera San Camillo Forlanini ( Site 1958) Roma,
Azienda Ospedaliera San Gerardo ( Site 1980) Monza, Lombardy
Azienda Ospedaliera Santa Maria ( Site 1962) Terni,
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1972) Brescia,
Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964) Parma,
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1974) Torino,
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967) Bergamo,
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 1030) São Paulo,
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1419) Kecskemét, Bács-Kiskun county
Ballarat Oncology & Haematology Services ( Site 3022) Wendouree, Victoria
Baptist MD Anderson Cancer Center ( Site 0083) Jacksonville, Florida
Barts Health NHS Trust ( Site 0512) London, London, City of
Bashkir State Medical University ( Site 1221) Ufa, Baskortostan, Respublika
Baskent Universitesi Ankara Hastanesi ( Site 1303) Ankara,
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1307) Adana,
Beijing Cancer Hospital ( Site 3451) Beijing, Beijing Municipality
Beijing Cancer Hospital ( Site 3499) Beijing, Beijing Municipality
Beijing Cancer Hospital ( Site 3500) Beijing, Beijing Municipality
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 3454) Beijing, Beijing Municipality
Belfast City Hospital ( Site 0508) Belfast, Northern Ireland
Belgorod Oncology Dispensary ( Site 1213) Belgorod, Belgorod Oblast
Bezmialem Vakf Üniversitesi-Oncology ( Site 1308) Istanbul,
Bialostockie Centrum Onkologii ( Site 1610) Bialystok, Podlaskie Voivodeship
Biocenter ( Site 2763) Concepción, Biobio
Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801) Uppsala, Uppsala County
Blue Ridge Cancer Care ( Site 0067) Roanoke, Virginia
Bnai Zion Medical Center ( Site 2060) Haifa,
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0075) Midlothian, Virginia
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 1409) Miskolc, Borsod-Abauj Zemplen county
Bradford Hill Norte ( Site 2761) Antofagasta,
Bradfordhill-Clinical Area ( Site 2756) Santiago, Region M. de Santiago
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1405) Gyula, Bekes County
C.H.U. Pontchaillou ( Site 2511) Pierre-Bénite, Rhone
C.H.U. de Tours - Hopital Bretonneau ( Site 2515) Tours, Indre-et-Loire
CELAN,S.A ( Site 3405) Guatemala City,
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 1034) Florianópolis, Santa Catarina
CEPON ( Site 1012) Florianópolis, Santa Catarina
CH Lyon Sud Hospices Civils de Lyon ( Site 2521) Pierre-Bénite, Auvergne-Rhône-Alpes
CHA Bundang Medical Center CHA University ( Site 0957) Seongnam-si, Kyonggi-do
CHRU Brest - Hopital Cavale Blanche ( Site 2504) Brest, Finistere
CHRU Lille Hospital Claude Huriez ( Site 2506) Lille, Nord
CHU Bordeaux Haut-Leveque ( Site 2534) Pessac, Aquitaine
CHU Hopital Saint Antoine ( Site 2517) Paris,
CHU Jean Minjoz ( Site 2520) Besançon, Doubs
CHU La Timone ( Site 2508) Marseille, Bouches-du-Rhone
CHU Montpellier. ( Site 2556) Montpellier, Herault
CHU Toulouse - Hopital Rangueil ( Site 2518) Toulouse, Haute-Garonne
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 2526) Toulouse, Haute-Garonne
CHU-Jean Minjoz ( Site 2550) Besançon, Doubs
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0876) Santiago de Compostela, La Coruna
CIDO SpA ( Site 2765) Temuco, Araucania
CIMCA ( Site 3900) San José,
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 3671) Cherkasy, Cherkasy Oblast
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1024) Fortaleza, Ceará
Cabinet Medical Oncomed ( Site 3554) Timișoara, Timiș County
California Cancer Associates for Research & Excellence ( Site 0016) Fresno, California
Calvary Mater Newcastle ( Site 3005) Waratah, New South Wales
Cancer Institute Hospital of JFCR ( Site 3108) Tokyo,
Cancer Institute Hospital of JFCR ( Site 3146) Koto, Tokyo
Cancer Institute Hospital of JFCR ( Site 3164) Koto, Tokyo
Cancer Institute of New Jersey ( Site 0025) New Brunswick, New Jersey
CancerCare Manitoba ( Site 2814) Winnipeg, Manitoba
Canterbury Regional Cancer & Blood Service ( Site 1500) Christchurch, Canterbury
Cape Town Oncology Trials ( Site 2007) Cape Town, Western Cape
Capital & Coast District Health Board - Wellington Hospital ( Site 1501) Wellington,
Cardiomed SRL Cluj-Napoca ( Site 3555) Cluj-Napoca, Cluj
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525) Rennes, Ille-et-Vilaine
Centre Francois Baclesse ( Site 2558) Caen, Calvados
Centre Georges François Leclerc-Centre de recherche clinique ( Site 2536) Dijon, Cote-d Or
Centre Henri Becquerel ( Site 2547) Rouen, Seine-Maritime
Centre Hopitalar Leon-Berard ( Site 2519) Lyon, Auvergne
Centre Hospitalier Annecy Genevois ( Site 2554) Epagny Metz Tessy, Haute-Savoie
Centre Hospitalier Intercommunal de Créteil ( Site 2514) Créteil, Val-de-Marne
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2539) Nice, Alpes-Maritimes
Centre Hospitalier Universitaire de Poitiers-Dermatologie ( Site 2544) Poitiers, Vienne
Centre Hospitalier de Pau ( Site 2563) Pau, Pyrenees-Atlantiques
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807) Montreal, Quebec
Centre Hospitalier du Mans-Pneumologie ( Site 2527) Le Mans, Sarthe
Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava ( Site 2810) Laval, Quebec
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre-Oncology ( Site 2809) Greenfield Park, Quebec
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 2542) Clermont-Ferrand, Puy-de-Dome
Centre Oscar Lambret ( Site 2551) Lille, Hauts-de-France
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 2816) Trois-Rivières, Quebec
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 2805) Québec, Quebec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 2812) Sherbrooke, Quebec
Centro Hospitalar de Sao Joao - Hospital de Sao Joao ( Site 1752) Porto,
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0869) Madrid,
Centro Medico Privado CEMAIC ( Site 1371) Córdoba,
Centro Medico San Roque-Oncology ( Site 1352) San Miguel de Tucumán,
Centro Oncologico Norte. ( Site 1370) Santiago del Estero,
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 1368) Buenos Aires., Buenos Aires
Centro de Estudios Clínicos SAGA ( Site 2767) Santiago, Region M. de Santiago
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. ( Site 1119) Ciudad Madero, Tamaulipas
Centro de Inmuno Oncología de Occidente SA de CV ( Site 1115) Guadalajara, Jalisco
Centro de Investigaciones ( Site 2755) Viña del Mar, Valparaiso
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1041) Itajaí, Santa Catarina
Centro de Oncología e Investigación de Buenos Aires ( Site 1357) Berazategui, Buenos Aires
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 1016) Fortaleza, Ceará
Centro de Urologa Avanzada del Noreste ( Site 1110) San Pedro Garza García, Nuevo León
Centrul de Oncologie "Sfântul Nectarie" ( Site 3552) Craiova, Dolj
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1612) Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Chaim Sheba Medical Center ( Site 2055) Ramat Gan,
Chaim Sheba Medical Center. ( Site 2052) Ramat Gan,
Champalimaud Foundation ( Site 1751) Lisbon, Lisbon District
Chang Gung Medical Foundation-Linkou Branch ( Site 3206) Taoyuan,
Changhua Christian Hospital ( Site 3210) Changhua,
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2424) Berlin,
Chiba Cancer Center ( Site 3117) Chiba,
China Medical University Hospital ( Site 3204) Taichung,
Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 3466) Beijing, Beijing Municipality
Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 0959) Hwasun, Jeonranamdo
Chris OBrien Lifehouse ( Site 3003) Camperdown, New South Wales
Chulalongkorn University ( Site 2363) Pathumwan, Bangkok
Chungbuk National University Hospital ( Site 0961) Cheongju-si, North Chungcheong
Chungnam national university hospital-Department of Internal Medicine ( Site 0958) Daejeon, Taejon-Kwangyokshi
City Clinical Oncology Center ( Site 1237) Saint Petersburg, Sankt-Peterburg
Clinica Universitaria de Navarra ( Site 0855) Madrid,
Clinica Viedma ( Site 1353) Viedma, Río Negro Province
Clinica Viver ( Site 1021) Santa Maria, Rio Grande do Sul
Clinica de la Costa S.A.S. ( Site 2705) Barranquilla, Atlántico
Clinical Research Center of specialized types medical care-Oncology ( Site 1205) Saint Petersburg, Sankt-Peterburg
Clinique de L'Europe ( Site 2548) Amiens, Somme
Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905) Brussels, Bruxelles-Capitale, Region de
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 2911) Brussels, Bruxelles-Capitale, Region de
Clínica Imbanaco S.A.S ( Site 2708) Cali, Valle del Cauca Department
Clínica Inmunocel ( Site 2762) Santiago, Region M. de Santiago
Clínica Universitaria Reina Fabiola ( Site 1376) Córdoba,
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA ( Site 1017) São Paulo, São Paulo
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 3663) Ivano-Frankivsk, Ivano-Frankivsk Oblast
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 3662) Vinnytsia, Vinnytsia Oblast
Complejo Hospitalario de Jaén-Servicio de Oncología Médica ( Site 0879) Jaén,
Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) Bakersfield, California
Comprehensive Cancer Centers of Nevada ( Site 0043) Las Vegas, Nevada
Cross Cancer Institute ( Site 2804) Edmonton, Alberta
Cuidados Oncologicos. ( Site 1118) Querétaro,
Dana-Farber Cancer Institute ( Site 0006) Boston, Massachusetts
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 1415) Debrecen,
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1412) Debrecen,
Derma Internacional SA ( Site 1372) CABA, Buenos Aires
Dokkyo Medical University Saitama Medical Center ( Site 3152) Koshigaya, Saitama
Dokuz Eylul Universitesi Hastanesi ( Site 1323) Balçova, İzmir
Duke Cancer Center ( Site 0028) Durham, North Carolina
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300) Izmir,
Ehime University Hospital ( Site 3158) Tōon, Ehime
Elbe Klinikum Buxtehude ( Site 2400) Buxtehude, Lower Saxony
Emek Medical Center ( Site 2072) Afula,
Emory School of Medicine ( Site 0013) Atlanta, Georgia
Erasmus MC ( Site 1553) Rotterdam, South Holland
EuroCityClinic ( Site 1230) Saint Petersburg, Sankt-Peterburg
European Interbalkan Medical Center ( Site 1855) Thessaloniki,
FDI Clinical Research ( Site 1152) San Juan,
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208) Moscow, Moscow
FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1234) Moscow, Moscow
Facharztzentrum Eppendorf ( Site 2415) Hamburg,
Faculty of Medicine - Khon Kaen University ( Site 2366) Muang, Changwat Khon Kaen
Faculty of Medicine Siriraj Hospital ( Site 2365) Bangkoknoi, Bangkok
Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0702) Prague, Praha 4
Fakultni nemocnice Olomouc ( Site 0701) Olomouc,
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0704) Olomouc, Olomouc Region
Fakultni nemocnice v Motole ( Site 0700) Prague,
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0705) Prague, Praha 5
Farkasgyepui Tudogyogyintezet-Pulmonologia ( Site 1414) Farkasgyepű, Veszprém megye
Fejér Megyei Szent György Egyetemi Oktató Kórház-l.Pulmonologia ( Site 1407) Székesfehérvár, Fejér
Fiona Stanley Hospital ( Site 3029) Murdock, Western Australia
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1245) Moscow, Moscow
First Pavlov State Medical University of Saint Petersburg ( Site 1232) Saint Petersburg, Sankt-Peterburg
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1977) Milan, Lombardy
Fondazione IRCCS Policlinico San Matteo ( Site 1982) Pavia,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1975) Rome, Lazio
Fourth Hospital of Hebei Medical University ( Site 3520) Shijiazhuang, Hebei
Fox Chase Cancer Center ( Site 0042) Philadelphia, Pennsylvania
Fred Hutchinson Cancer Center ( Site 0024) Bellevue, Washington
Fudan University Shanghai Cancer Center ( Site 3467) Shanghai, Shanghai Municipality
Fujian Provincial Cancer Hospital ( Site 3461) Fuzhou, Fujian
Fundacion Arturo Lopez Perez FALP ( Site 2750) Santiago, Region M. de Santiago
Fundacion Colombiana de Cancerología Clinica Vida ( Site 2707) Medellín, Antioquia
Fundacion Estudios Clinicos ( Site 1369) Rosario, Santa Fe Province
Fundacion Favaloro ( Site 1367) CABA, Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1358) La Rioja,
Fundación Valle del Lili ( Site 2700) Cali, Valle del Cauca Department
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1003) São José do Rio Preto, São Paulo
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1010) Barretos, São Paulo
GBUZ LOKB ( Site 1218) Saint-Petersburg, Leningradskaya Oblast'
GBUZ LOKB-Oncology department #1 ( Site 1222) Saint-Petersburg, Leningradskaya Oblast'
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1250) Ufa, Baskortostan, Respublika
GBUZ SK Pyatigorsk Interdistrict Oncology dispensary ( Site 1223) Pyatigorsk, Stavropol Kray
GVI Oncology ( Site 2008) George, Western Cape
Gachon University Gil Medical Center ( Site 0967) Inceon, Incheon
Gallipoli Medical Research Ltd ( Site 3011) Brisbane, Queensland
Gangnam Severance Hospital, Yonsei University Health System ( Site 0966) Gangnam-gu, Seoul
Gazi University Health Research and Application Center Gazi Hospital ( Site 1325) Ankara,
General Hospital of Athens "Laiko"-Hematology Department ( Site 1851) Athens, Attica
Georgetown University Medical Center ( Site 0023) Washington D.C., District of Columbia
Gifu University Hospital ( Site 3161) Gifu,
Gleneagles Penang ( Site 0625) George Town, Pulau Pinang
Gold Coast University Hospital ( Site 3028) Southport, Queensland
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2545) Paris,
Groupe hospitalier Paris saint Joseph-Service de Pneumologie-Allergologie -Oncologie Thoracique ( Site 2533) Paris, Île-de-France Region
Grupo Medico Angeles ( Site 3402) Guatemala City,
Guangdong Provincial People's Hospital-Cancer Center ( Site 3462) Guangzhou, Guangdong
H. Marques de Valdecilla ( Site 0865) Santander, Cantabria
H.R.U Malaga - Hospital General ( Site 0884) Málaga, Malaga
H.U. Vall de Hebron ( Site 0850) Barcelona,
HENRI MONDOR HOSPITAL ( Site 2561) Créteil, Val-de-Marne
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0872) Seville,
Hacettepe Universitesi-oncology hospital ( Site 1304) Ankara,
Hadassah Ein Kerem Medical Center ( Site 2051) Jerusalem,
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801) Hamilton, Ontario
Hangzhou Cancer Hospital-Medical Oncology ( Site 3468) Hangzhou, Zhejiang
Hanoi Oncology Hospital ( Site 3780) Hanoi, Hanoi
Harbin Medical University Cancer Hospital ( Site 3506) Harbin, Heilongjiang
Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3475) Harbin, Heilongjiang
Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 2418) Berlin,
Helse Bergen Haukeland universitetssykehus ( Site 1451) Bergen, Vestfold
Henan Cancer Hospital ( Site 3488) Zhengzhou, Henan
Hiroshima City Hiroshima Citizens Hospital ( Site 3119) Hiroshima,
Hiroshima University Hospital ( Site 3154) Hiroshima,
Hokkaido University Hospital ( Site 3165) Sapporo, Hokkaido
Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) Fort Lauderdale, Florida
Hopital Cochin ( Site 2509) Paris,
Hopital Nord ( Site 2516) Marseille, Bouches-du-Rhone
Hopital Saint Louis ( Site 2510) Paris,
Hopital Trousseau ( Site 2512) Chambray-lès-Tours, Indre-et-Loire
Hospital Aleman-Oncology ( Site 1351) Buenos Aires,
Hospital Amaral Carvalho ( Site 1023) Jaú, São Paulo
Hospital Arnau de Vilanova ( Site 0866) Valencia, Valenciana, Comunitat
Hospital Cayetano Heredia-Oncology ( Site 0675) Lima,
Hospital Clinic de Barcelona ( Site 0852) Barcelona, Catalonia
Hospital Clinico San Carlos ( Site 0857) Madrid,
Hospital Clinico Universitario Lozano Blesa ( Site 0859) Zaragoza,
Hospital Clinico de Valencia ( Site 0858) Valencia, Valenciana, Comunitat
Hospital Erasto Gaertner ( Site 1036) Curitiba, Paraná
Hospital General Universitario 12 de Octubre ( Site 0856) Madrid,
Hospital General Universitario de Alicante-Oncologia ( Site 0881) Alicante,
Hospital General Universitario de Valencia ( Site 0854) Valencia, Valenciana, Comunitat
Hospital Metropolitano - Sede Lindora ( Site 3901) Santa Ana, Provincia de San José
Hospital Nossa Senhora da Conceição ( Site 1011) Porto Alegre, Rio Grande do Sul
Hospital Paulistano ( Site 1033) São Paulo,
Hospital Privado Universitario de Córdoba ( Site 1354) Córdoba,
Hospital Provincial del Centenario ( Site 1359) Rosario, Santa Fe Province
Hospital Pulau Pinang ( Site 0629) George Town, Pulau Pinang
Hospital Son Llatzer ( Site 0886) Palma de Mallorca, Balearic Islands
Hospital São Carlos-Oncocentro Ce ( Site 1029) Fortaleza, Ceará
Hospital São Lucas da PUCRS-Centro de Pesquisa em Oncologia ( Site 1006) Porto Alegre, Rio Grande do Sul
Hospital Tacchini ( Site 1040) Bento Gonçalves, Rio Grande do Sul
Hospital Tengku Ampuan Afzan ( Site 0627) Kuantan, Pahang
Hospital Universitari Sant Joan de Reus-Oncology ( Site 0874) Reus, Tarragona
Hospital Universitari Son Espases-Oncologia ( Site 0883) Palma, Balearic Islands
Hospital Universitari i Politecnic La Fe ( Site 0875) Valencia, Valencia
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 1113) Monterrey, Nuevo León
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0870) Oviedo, Principality of Asturias
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0871) Madrid,
Hospital Universitario Gregorio Maranon ( Site 0864) Madrid,
Hospital Universitario Insular de Gran Canaria ( Site 0867) Las Palmas de Gran Canaria, Las Palmas
Hospital Universitario La Paz ( Site 0853) Madrid,
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861) Majadahonda, Madrid
Hospital Universitario Quiron Madrid ( Site 0868) Pozuelo de Alarcón, Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0877) Madrid, Madrid, Comunidad de
Hospital Universitario Reina Sofia ( Site 0885) Córdoba,
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 0880) Seville,
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 0882) Seville,
Hospital Universitario Virgen de la Victoria ( Site 0878) Málaga,
Hospital Universitario de Donostia ( Site 0890) San Sebastian- Donostia, Basque Country
Hospital Vall d´Hebron Skin Cancer & Woman cancer therapeutic area ( Site 0887) Barcelona,
Hospital de Clinicas de Porto Alegre ( Site 1000) Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Passo Fundo ( Site 1025) Passo Fundo, Rio Grande do Sul
Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 0862) Barcelona, Catalonia
Humanitas Gavazzeni ( Site 1954) Bergamo,
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968) Rozzano, Milano
Hunan Cancer Hospital ( Site 3485) Changsha, Hunan
Hunan Cancer Hospital ( Site 3501) Changsha, Hunan
Hyogo Cancer Center ( Site 3131) Akashi, Hyōgo
Hyogo Medical University Hospital ( Site 3100) Nishinomiya, Hyōgo
Hôpital Avicenne-Dermatologie ( Site 2538) Bobigny, Seine-Saint-Denis
Hôpital Beaujon ( Site 2524) Clichy, Île-de-France Region
Hôpital Foch ( Site 2543) Suresnes, Hauts-de-Seine
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-lung oncology ( Site 2546) Saint-Herblain, Loire-Atlantique
Hôpital Privé Clairval ( Site 2549) Marseille, Bouches-du-Rhone
Hôpital Tenon ( Site 2530) Paris,
Hôpital Universitaire Paul Brousse ( Site 2541) Villejuif, Val-de-Marne
Hôpitaux Universitaires de Genève (HUG) ( Site 0753) Geneva, Canton of Geneva
I Can Oncology Center SA de CV ( Site 1116) Monterrey, Nuevo León
I.E.U. Medical Point Hastanesi-Oncology ( Site 1310) Izmir,
IC La Serena Research ( Site 2766) La Serena, Coquimbo Region
IDIM - Instituto de Investigaciones Metabólicas ( Site 1362) Ciudad de Buenos Aires, Buenos Aires
IMAT S.A.S ( Site 2703) Montería, Departamento de Córdoba
INOC - Istituto Nazionale Oncologico Candiolo ( Site 1960) Candiolo, Torino
INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1102) Mexico City, Mexico City
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0681) Lima,
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0678) Lima,
IRCCS A.O.U. San Martino - IST ( Site 1961) Genova,
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1978) Bologna, Emilia-Romagna
IRCCS CRO Aviano, Hematology/Oncology ( Site 1957) Aviano, Pordenone
Ibaraki Prefectural Central Hospital ( Site 3180) Kasama, Ibaraki
Inonu Universitesi ( Site 1309) Malatya,
Institut Bergonie ( Site 2502) Bordeaux, Gironde
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851) Badalona, Catalonia
Institut Gustave Roussy ( Site 2513) Villejuif, Île-de-France Region
Institut Jules Bordet ( Site 2903) Anderlecht, Bruxelles-Capitale, Region de
Institut Kanser Negara - National Cancer Institute ( Site 0630) Putrajaya - Wilayah Persekutuan, Putrajaya
Institut Sainte Catherine ( Site 2557) Avignon, Vaucluse
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 2560) Toulouse, Haute-Garonne
Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 2532) Vandœuvre-lès-Nancy, Lorraine
Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522) Saint-Herblain, Loire-Atlantique
Institute of Science Tokyo Hospital ( Site 3149) Bunkyō, Tokyo
Instituto Alexander Fleming ( Site 1364) Ciudad Autónoma de Buenos Aires, Buenos Aires
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860) L'Hospitalet de Llobregat, Barcelona
Instituto Médico Río Cuarto ( Site 1375) Río Cuarto, Córdoba Province
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 2706) Bogota, Cundinamarca
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 1020) Rio de Janeiro,
Instituto Nacional del Cancer-CR Investigación ( Site 2753) Santiago, Region M. de Santiago
Instituto Português de Oncologia do Porto Francisco Gentil, EPE-Oncologia Médica ( Site 1753) Porto,
Instituto San Marcos ( Site 1366) San Juan,
Instituto Valenciano de Oncologia - IVO ( Site 0863) Valencia, Valenciana, Comunitat
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363) Mar del Plata, Buenos Aires
Instituto de Oncologia Saint Gallen ( Site 1039) Ssanta Cruz Do Sul, Rio Grande do Sul
Instituto de Oncologia de Rosario ( Site 1350) Rosario, Santa Fe Province
Instituto de de Educação, pesquisa e Gestão em Saúde ( Site 1014) Rio de Janeiro,
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001) São Paulo,
Institutul Oncologic "Prof. Dr. Ioan Chiricuta" ( Site 3551) Cluj-Napoca,
Instytut Centrum Zdrowia Matki Polki-Klinika Onkologii ( Site 1609) Lodz, Łódź Voivodeship
Investigación Oncofarmacéutica-Investigación clínica ( Site 1114) La Paz, Baja California Sur
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1035) Porto Alegree, Rio Grande do Sul
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302) Istanbul,
Istanbul University Capa Campus ( Site 1314) Istanbul,
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 1963) Rome, Lazio
Istituto Europeo di Oncologia ( Site 1952) Milan,
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Naples,
Istituto Oncologico Veneto IRCCS ( Site 1976) Padova, Veneto
Iwate Medical University Hospital ( Site 3157) Shiwa-gun, Iwate
James Graham Brown Cancer Center ( Site 0058) Louisville, Kentucky
James Lind Centro de Investigacion del Cancer ( Site 2757) Temuco, Araucania
Jewish General Hospital ( Site 2800) Montreal, Quebec
Jiangsu Cancer Hospital-Medical Oncotherapy ( Site 3469) Nanjing, Jiangsu
Jichi Medical University Hospital ( Site 3141) Shimotsuke, Tochigi
Jilin Province Tumor Hospital ( Site 3484) Changchun, Jilin
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038) Hackensack, New Jersey
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1401) Szolnok, Jász-Nagykun-Szolnok
K Hospital - National Cancer Hospital ( Site 3783) Hanoi, Hanoi
Kagawa University Hospital ( Site 3171) Kita, Kagawa-ken
Kaiser Permanente Moanalua Medical Center ( Site 0063) Honolulu, Hawaii
Kanagawa Cancer Center ( Site 3137) Yokohama, Kanagawa
Kanazawa University Hospital ( Site 3140) Kanazawa, Ishikawa-ken
Kansai Medical University Hospital ( Site 3126) Hirakata, Osaka
Kaohsiung Chang Gung Memorial Hospital ( Site 3203) Kaohsiung City,
Karmanos Cancer Institute ( Site 0047) Detroit, Michigan
Karolinska Universitetssjukhuset Solna ( Site 0802) Stockholm, Stockholm County
Keimyung University Dongsan Hospital CRC room 1 ( Site 0960) Daegu, Taegu-Kwangyokshi
Keio University Hospital ( Site 3127) Tokyo,
Kepler Universitätsklinikum ( Site 2955) Linz, Upper Austria
Kindai University Hospital ( Site 3102) Sakai, Osaka
Kindai University Hospital ( Site 3135) Sakai, Osaka
Kindai University Hospital ( Site 3166) Sakai, Osaka
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808) Kingston, Ontario
Kitasato University Hospital ( Site 3142) Sagamihara, Kanagawa
Klaipeda University Hospital-Oncology chemotherapy ( Site 3302) Klaipėda, Klaipedos Miestas
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2954) Vienna,
Kobe City Medical Center General Hospital ( Site 3144) Kobe, Hyōgo
Kocaeli Üniversitesi ( Site 1313) Kocaeli,
Kochi Health Sciences Center ( Site 3145) Kochi,
Koo Foundation Sun Yat-Sen Cancer Center-Gynecology, Obstetrics, and women's health ( Site 3207) Taipei,
Korea University Anam Hospital ( Site 0956) Seoul,
Korea University Guro Hospital ( Site 0963) Seoul,
Krankenhaus Nordwest ( Site 2409) Frankfurt am Main, Hesse
Kumamoto University Hospital ( Site 3179) Kumamoto,
Kurashiki Central Hospital ( Site 3132) Kurashiki, Okayama-ken
Kurume University Hospital ( Site 3105) Kurume, Fukuoka
Kyorin University Hospital ( Site 3103) Mitaka, Tokyo
Kyorin University Hospital ( Site 3147) Mitaka-shi, Tokyo
Kyoto University Hospital ( Site 3181) Kyoto,
Kyungpook National University Chilgok Hospital ( Site 0964) Deagu, Taegu-Kwangyokshi
Kyushu University Hospital ( Site 3143) Fukuoka,
Kyushu University Hospital ( Site 3185) Fukuoka,
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2005) Pretoria, Gauteng
LLC Clinic Verum Expert ( Site 3669) Kyiv, Kyivska Oblast
LLC Medical Centre "Lotos" ( Site 1253) Chelyabinsk, Chelyabinsk Oblast
Lacks - Oncologia E Hematologia ( Site 1026) Pelotas, Rio Grande do Sul
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032) New York, New York
Levine Cancer Institute ( Site 0034) Charlotte, North Carolina
Liepjas reionl slimnca ( Site 3851) Liepāja,
LinYi Cancer Hospital ( Site 3511) Linyi, Shandong
Liv Hospital Ankara ( Site 1330) Ankara,
Liverpool Hospital-Medical Oncology ( Site 3021) Liverpool, New South Wales
London Health Sciences Centre ( Site 2806) London, Ontario
Lung Center of the Philippines ( Site 1705) Quezon City, National Capital Region
LungenClinic Grosshansdorf GmbH ( Site 2412) Großhansdorf, Schleswig-Holstein
Luxmed Onkologia sp. z o. o. ( Site 1621) Warsaw, Masovian Voivodeship
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 3668) Dnipro, Dnipropetrovsk Oblast
MEDI-K ( Site 3403) Guatemala City,
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 3553) Bucharest, Bucharest
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 3657) Kryvyi Rih, Dnipropetrovsk Oblast
MNE "Khmelnytskyi regional antitumor center" ( Site 3675) Khmelnytskyi, Khmelnytskyi Oblast
MNPE Regional Center of Oncology ( Site 3665) Kharkiv, Kharkiv Oblast
Mackay Memorial Hospital ( Site 3205) Taipei,
Macquarie University ( Site 3010) Macquarie University, New South Wales
Makati Medical Center ( Site 1702) Makati City, National Capital Region
Markusovszky Egyetemi Oktatokorhaz-Onkológiai Osztály ( Site 1410) Szombathely, Vas County
Marmara Universitesi Pendik Egitim Arastirma Hastanesi-Medical Oncology ( Site 1305) Istanbul,
Maryland Oncology Hematology (MOH) ( Site 8000) Columbia, Maryland
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0703) Brno, Brno-mesto
Massachusetts General Hospital ( Site 0041) Boston, Massachusetts
Mater Hospital Sydney ( Site 3007) North Sydney, New South Wales
Mater Misercordiae University Hospital ( Site 1800) Dublin, Leinster
Mater Misericordiae Limited-Medical Oncology ( Site 3019) Brisbane, Queensland
Mayo Clinic in Rochester, Minnesota ( Site 0002) Rochester, Minnesota
McGill University Health Centre ( Site 2818) Montreal, Quebec
Med-Polonia Sp. z o. o. ( Site 1605) Poznan, Greater Poland Voivodeship
MedStar Franklin Square Medical Center ( Site 0046) Baltimore, Maryland
Medical Care and Research SA de CV ( Site 1103) Mérida, Yucatán
Medical University of Graz ( Site 2952) Graz, Styria
Medipol Mega Universite Hastanesi ( Site 1326) Istanbul,
Medizinische Hochschule Hannover ( Site 2402) Hanover, Lower Saxony
Medizinische Universitaet Innsbruck ( Site 2951) Innsbruck, Tyrol
Medizinische Universität Wien ( Site 2953) Vienna,
Melanoma Institute Australia ( Site 3001) Wollstonecraft, New South Wales
Memorial Antalya Hospital-Oncology ( Site 1315) Antalya,
Memorial Sloan Kettering Cancer Center ( Site 0012) New York, New York
Mercy Health-Paducah Cancer Center ( Site 0084) Paducah, Kentucky
Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503) Broomfield, Essex
Miyagi Cancer Center ( Site 3122) Natori-shi, Miyagi
Moffitt Cancer Center ( Site 0011) Tampa, Florida
Monash Health ( Site 3015) Clayton, Victoria
Mount Sinai Braman Comprehensive Cancer Center ( Site 0031) Miami Beach, Florida
Mount Sinai Hospital ( Site 2811) Toronto, Ontario
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council ( Site 3650) Dnipro, Dnipropetrovsk Oblast
Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653) Lviv, Lviv Oblast
Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City ( Site 3651) Kyiv, Kyivska Oblast
Municipal non-profit enterprise "Zaporizhzhia regional clinical hospital" of Zaporizhzhia regional c ( Site 3664) Zaporizhzhya, Zaporizhzhia Oblast
Mátrai Gyógyintézet ( Site 1417) Gyöngyös, Heves County
N.N. Blokhin NMRCO ( Site 1209) Moscow, Moscow
N.N.Petrov Research Institute of Oncology-Department of Preclinical and Clinical Research ( Site 1211) Saint Petersburg, Sankt-Peterburg
Nagoya University Hospital ( Site 3151) Nagoya, Aichi-ken
Nanfang Hospital of Southern Medical University ( Site 3509) Guangzhou, Guangdong
Nara Medical University Hospital ( Site 3110) Kashihara, Nara
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1620) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 1608) Krakow, Lesser Poland Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1604) Warsaw, Masovian Voivodeship
National Cancer Center ( Site 0955) Goyang-si, Kyonggi-do
National Cancer Center Hospital ( Site 3130) Tokyo,
National Cancer Center Hospital East ( Site 3121) Kashiwa, Chiba
National Cancer Centre Singapore ( Site 2200) Singapore, Central Singapore
National Cancer Institute-Department of Minimally Invasive and Endoscopic Surgery, Interventional R ( Site 3658) Kyiv, Kyivska Oblast
National Cheng Kung University Hospital ( Site 3201) Tainan,
National Defense Medical College Hospital ( Site 3177) Tokorozawa, Saitama
National Hospital Organization Himeji Medical Center ( Site 3111) Himeji, Hyōgo
National Hospital Organization Hokkaido Cancer Center ( Site 3160) Sapporo, Hokkaido
National Hospital Organization Kyushu Cancer Center ( Site 3169) Fukuoka,
National Hospital Organization Kyushu Medical Center ( Site 3136) Fukuoka,
National Hospital Organization Nagoya Medical Center ( Site 3109) Nagoya, Aichi-ken
National Hospital Organization Osaka National Hospital ( Site 3162) Osaka,
National Hospital Organization Shikoku Cancer Center ( Site 3116) Matsuyama, Ehime
National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123) Ube, Yamaguchi
National Lung Hospital ( Site 3781) Hanoi, Hanoi
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1210) Saint Petersburg, Sankt-Peterburg
National Taiwan University Hospital ( Site 3200) Taipei,
National Taiwan University Hospital - Hsinchu branch ( Site 3208) Hsinchu,
National University Hospital-Haematology -Oncology Research Group ( Site 2201) Singapore, South West
New Cross Hospital-Department of Oncology ( Site 0517) Wolverhampton,
Niigata Cancer Center Hospital ( Site 3173) Niigata, Niigata
Niigata University Medical & Dental Hospital ( Site 3174) Niigata,
Nippon Medical School Hospital ( Site 3139) Tokyo,
Nippon Medical School Musashi Kosugi Hospital ( Site 3178) Kawasaki, Kanagawa
Norrlands Universitetssjukhus ( Site 0800) Umeå, Västerbotten County
Northern Jiangsu People's Hospital-General Surgery Department ( Site 3474) Yangzhou, Jiangsu
Northwest Georgia Oncology Centers PC ( Site 0061) Marietta, Georgia
Nottingham University Hospitals NHS Trust ( Site 0510) Nottingham, Nottinghamshire
Nouvel Hôpital Civil (NHC) ( Site 2529) Strasbourg, Alsace
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1018) São Paulo,
ONCOCENTRO APYS-ACEREY ( Site 2758) Viña del Mar, Valparaiso
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1008) Ijuí, Rio Grande do Sul
Oaxaca Site Management Organization ( Site 1106) Oaxaca City, Oaxaca
Obstetrics & Gynecology Hospital of Fudan University ( Site 3494) Shanghai, Shanghai Municipality
Odense Universitetshospital ( Site 0650) Odense, Region Syddanmark
Odessa Regional Oncology Center ( Site 3655) Odesa, Odesa Oblast
Ogarev Mordovia State University ( Site 1206) Saransk, Mordoviya, Respublika
Okayama University Hospital ( Site 3107) Okayama,
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0082) Tulsa, Oklahoma
Oncare Viaducto Napoles ( Site 1107) Mexico City,
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1244) Sochi, Krasnodarskiy Kray
Oncologos del Occidente ( Site 2709) Pereira, Risaralda Department
Oncomedica ( Site 3401) Guatemala City,
Oncovida ( Site 2759) Santiago, Region M. de Santiago
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Kosza-Klinika Onkologii z Odcinkiem Dziennym ( Site 1616) Opole, Opole Voivodeship
Orange Hospital-Clinical Trials Unit ( Site 3027) Orange, New South Wales
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 2957) Linz, Upper Austria
Orlandi Oncologia-Oncology ( Site 2752) Santiago, Region M. de Santiago
Orszagos Koranyi Pulmonologiai Intezet ( Site 1403) Budapest,
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1411) Budapest, Pest County
Osaka City General Hospital ( Site 3125) Osaka,
Osaka General Medical Center ( Site 3184) Osaka,
Osaka Habikino Medical Center ( Site 3138) Habikino, Osaka
Osaka Medical and Pharmaceutical University Hospital ( Site 3167) Takatsuki, Osaka
Osaka Medical and Pharmaceutical University Hospital ( Site 3187) Takatsuki, Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3129) Osaka,
Osaka Rosai Hospital ( Site 3148) Sakai, Osaka
Oslo Universitetssykehus Radiumhospitalet ( Site 1450) Oslo,
Oslo universitetssykehus, Radiumhospitalet ( Site 1452) Oslo,
Ospedale Cannizzaro ( Site 1981) Catania, Sicily
Ospedale San Luigi Gonzaga ( Site 1956) Orbassano, Torino
Ospedale San Raffaele. ( Site 1979) Milan,
P. A. Hertsen Moscow Oncology Research Center ( Site 1214) Moscow, Moscow
P. A. Hertsen Moscow Oncology Research Center ( Site 1247) Moscow, Moscow
Palmerston North Hospital, MidCentral DHB ( Site 1504) Palmerston North, Manawatu-Wanganui
Pantai Hospital Kuala Lumpur ( Site 0628) Kuala Lumpur,
Parc de Salut Mar - Hospital del Mar-Oncologia ( Site 0873) Barcelona,
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3008) Melbourne, Victoria
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1408) Győr, Győr-Moson-Sopron
Policlinico Universitario Agostino Gemelli ( Site 1965) Roma,
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 2751) Santiago, Region M. de Santiago
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020) Port Macquarie, New South Wales
Powiatowe Centrum Zdrowia w Brzezinach Sp. z o. o. Oddział Dziennej Chemioterapii ( Site 1611) Brzeziny, Łódź Voivodeship
Princess Alexandra Hospital ( Site 3002) Woolloongabba, Queensland
Princess Margaret Cancer Centre ( Site 2803) Toronto, Ontario
Princess Margaret Hospital ( Site 1903) Hong Kong,
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656) Kropyvnytskyi, Kirovohrad Oblast
Promotora Médica Las Américas S.A. ( Site 2702) Medellín, Antioquia
Providence Medical Foundation ( Site 0087) Fullerton, California
Providence Portland Medical Center ( Site 0051) Portland, Oregon
Providence Saint John's Health Center ( Site 0059) Santa Monica, California
Przychodnia Lekarska KOMED ( Site 1603) Konin, Greater Poland Voivodeship
Queen Mary Hospital ( Site 1902) Hksar,
Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900) Hksar,
RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch ( Site 3850) Riga,
Rabin Medical Center ( Site 2059) Petah Tikva,
Radboud University Medical Center ( Site 1554) Nijmegen, Gelderland
Ramathibodi Hospital. ( Site 2364) Bangkok, Bangkok
Rambam Health Care Campus-Oncology Division ( Site 2053) Haifa,
Reformatus Pulmonologiai Centrum ( Site 1418) Törökbálint, Pest County
Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'-Urology ( Site 1219) Ivanovo, Ivanovo Oblast
Republican Clinical Oncology Dispensary ( Site 1228) Kazan', Tatarstan, Respublika
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204) Ufa, Baskortostan, Respublika
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1203) Kazan', Tatarstan, Respublika
Royal Adelaide Hospital ( Site 3014) Adelaide, South Australia
Royal Brisbane and Women's Hospital ( Site 3009) Herston, Queensland
Royal Free Hospital ( Site 0507) London, London, City of
Royal Marsden Hospital ( Site 0505) London, London, City of
Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025) St Leonards, New South Wales
Royal Preston Hospital ( Site 0518) Preston, Lancashire
Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016) Camperdown, New South Wales
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201) Moscow, Moscow
Russian Scientific Center of Roentgenoradiology ( Site 1215) Moscow, Moscow
Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 1224) Saint Petersburg, Sankt-Peterburg
SAIH of the Tyumen region, Multidisciplinary Clinical Medical Center "Medical town" ( Site 1220) Tyumen, Tyumen Oblast
SO"Grigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine" ( Site 3666) Kharlkiv, Kharkiv Oblast
SRH Wald-Klinikum Gera GmbH ( Site 2403) Gera, Thuringia
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 3452) Guangzhou, Guangdong
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 0803) Gothenburg, Västra Götaland County
Saint Francis Health System ( Site 0089) Greenville, South Carolina
Saitama Medical University International Medical Center ( Site 3118) Hidaka, Saitama
Saitama Prefectural Cancer Center ( Site 3112) Kitaadachi-gun, Saitama
Sakarya University School of Medicine ( Site 1332) Sakarya,
Samsun Medical Park Hastanesi ( Site 1328) Samsun,
Samsung Medical Center ( Site 0950) Seoul,
Samsung Medical Center ( Site 0970) Seoul,
Samsung Medical Center ( Site 0971) Seoul,
Sanatorio Parque ( Site 1355) Rosario, Santa Fe Province
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2004) Sandton, Gauteng
Sanford Cancer Center ( Site 0066) Sioux Falls, South Dakota
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0065) Fargo, North Dakota
Sapporo Kosei General Hospital ( Site 3172) Sapporo, Hokkaido
Sapporo Medical University Hospital ( Site 3113) Sapporo, Hokkaido
Sarah Cannon Research UK ( Site 0504) London, London, City of
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 1406) Budapest,
Sendai Kousei Hospital ( Site 3115) Sendai, Miyagi
Seoul National University Bundang Hospital ( Site 0951) Seongnam-si, Kyonggi-do
Seoul National University Hospital ( Site 0953) Seoul,
Severance Hospital ( Site 0954) Seoul,
Severance Hospital, Yonsei University Health System ( Site 0962) Seoul,
Shaare Zedek Medical Center ( Site 2068) Jerusalem,
Shamir Medical Center Assaf Harofeh ( Site 2058) Ẕerifin,
Shandong Cancer Hospital ( Site 3517) Jinan, Shandong
Shanghai Pulmonary Hospital ( Site 3470) Shanghai, Shanghai Municipality
Sheba Medical Center ( Site 2062) Ramat Gan,
Sheba Medical Center ( Site 2065) Ramat Gan,
Shizuoka Cancer Center ( Site 3128) Nakatogari, Shizuoka
Showa Medical University Hospital ( Site 3188) Shinagawa, Tokyo
Sichuan Cancer hospital. ( Site 3515) Chengdu, Sichuan
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056) Baltimore, Maryland
Sir Charles Gairdner Hospital ( Site 3006) Nedlands, Western Australia
Sir Run Run Shaw Hospital ( Site 3505) Hangzhou, Zhejiang
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2704) Valledupar, Cesar Department
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402) Kaposvár,
Songklanagarind Hospital ( Site 2367) Hat Yai, Changwat Songkhla
Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850) Athens, Attica
Sourasky Medical Center ( Site 2054) Tel Aviv,
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) San Antonio, Texas
Southern medical university Nangfang Hospital ( Site 3490) Guanghzou, Guangdong
Spitalul Județean Sfântul Ioan cel Nou Suceava-Oncology ( Site 3550) Suceava,
St James University Hospital ( Site 0509) Leeds,
St John of God Subiaco Hospital ( Site 3013) Subiaco, Western Australia
St Vincent's Hospital-Oncology Clinical Trials ( Site 3018) Melbourne, Victoria
St. James s Hospital ( Site 1801) Dublin,
St. Luke s Medical Center ( Site 1700) Quezon City, National Capital Region
St. Luke's University Health Network ( Site 0017) Easton, Pennsylvania
St. Marianna University Hospital ( Site 3182) Kawasaki, Kanagawa
St. Marys Hospital Center ( Site 2820) Montreal, Quebec
St. Petersburg Clinical Hospital of Russian Academy Of Sciences ( Site 1235) Saint Petersburg, Sankt-Peterburg
St.Luke's International Hospital ( Site 3120) Tokyo,
Stanford Cancer Center ( Site 0086) Palo Alto, California
Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 3661) Sumy, Sumska Oblast
Sun Yat-sen University Cancer Center-melanoma ( Site 3482) Guangzhou, Guangdong
Sunnybrook Research Institute ( Site 2802) Toronto, Ontario
Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 3032) Sunshine Coast, Queensland
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna ( Site 1601) Poznan, Greater Poland Voivodeship
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1625) Gdynia, Pomeranian Voivodeship
Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 1624) Racibórz, Silesian Voivodeship
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1618) Krakow, Lesser Poland Voivodeship
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1614) Koszalin, West Pomeranian Voivodeship
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1316) Istanbul,
Taichung Veterans General Hospital ( Site 3209) Taichung,
Taipei Medical University Hospital ( Site 3211) Taipei,
Taipei Veterans General Hospital ( Site 3202) Taipei,
Tallaght University Hospital ( Site 1803) Dublin,
Tampere University Hospital [Tampere Finland] ( Site 0600) Tampere, Pirkanmaa
Tangdu Hospital of Fourth Military Medical University of Chi-department of radiotherapy ( Site 3455) Xi'an, Shaanxi
Tartu University Hospital-Radiotherapy and oncology ( Site 3800) Tartu, Tartu
Tasman Oncology Research Pty Ltd ( Site 3012) Southport, Queensland
Teikyo University Hospital ( Site 3104) Tokyo,
Texas Oncology - Central/South Texas ( Site 8001) Austin, Texas
Texas Oncology-Baylor Sammons Cancer Center ( Site 0062) Dallas, Texas
The Affiliated Cancer Hospital of Guizhou Medical University ( Site 3498) Guiyang, Guizhou
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 3502) Ürümqi, Xinjiang
The Angeles Clinic and Research Institute ( Site 0005) Los Angeles, California
The Beatson West of Scotland Cancer Centre ( Site 0506) Glasgow, Glasgow City
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0972) Seoul,
The Catholic University Of Korea St. Vincent's Hospital ( Site 0968) Suwon, Kyonggi-do
The Christie ( Site 0516) Manchester, England
The Fifth Medical Center Of The Chinese PLA General Hospital (South) ( Site 3465) Beijing, Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 3460) Guangzhou, Guangdong
The First Affiliated Hospital of Nanchang University ( Site 3513) Nanchang, Jiangxi
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3489) XiAn, Shanxi
The First Affiliated Hospital of Xiamen University ( Site 3514) Xiamen, Fujian
The First Affiliated Hospital of Zhejiang University ( Site 3518) Hangzhou, Zhejiang
The First Affiliated Hospital, Sun Yat-sen University-pneumology department ( Site 3459) Guangzhou, Guangdong
The First Hospital of Jilin University-Oncology ( Site 3464) Changchun, Jilin
The Jikei University Hospital ( Site 3156) Tokyo,
The National Medico-Surgical Center N.I. Pirogov ( Site 1225) Moscow, Moscow
The Oncology Centre ( Site 2000) Durban, KwaZulu-Natal
The Ottawa Hospital - General Campus ( Site 2813) Ottawa, Ontario
The Queen Elizabeth Hospital ( Site 3026) Woodville, South Australia
The Royal Marsden NHS Foundation Trust. ( Site 0513) Sutton,
The Second People's Hospital of Yibin ( Site 3516) Yibin, Sichuan
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3491) Guangzhou, Guangdong
The Townsville Hospital ( Site 3017) Townsville, Queensland
The University of Chicago ( Site 0020) Chicago, Illinois
The University of Osaka Hospital ( Site 3168) Suita, Osaka
Tianjin Medical University Cancer Institute and Hospital ( Site 3456) Tianjin, Tianjin Municipality
Tohoku University Hospital ( Site 3175) Sendai, Miyagi
Tokyo Medical University Hospital ( Site 3170) Shinjuku-ku, Tokyo
Tokyo Metropolitan Komagome Hospital ( Site 3133) Tokyo,
Tomsk Scientific Research Institute of Oncology ( Site 1227) Tomsk, Tomsk Oblast
Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 3476) Wuhan, Hubei
Toranomon Hospital ( Site 3134) Minato-ku, Tokyo
Toranomon Hospital ( Site 3153) Minato-ku, Tokyo
Toranomon Hospital ( Site 3189) Minato, Tokyo
Toyama Prefectural Central Hospital ( Site 3183) Toyama,
Trakya Universitesi Tip Fakultesi ( Site 1301) Edirne,
Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652) Uzhhorod, Zakarpattia Oblast
Turku University Hospital ( Site 0601) Turku, Southwest Finland
UCLA - Hematology/Oncology - Administrative Office ( Site 0009) Los Angeles, California
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) San Francisco, California
UNIVERSIDAD CATÓLICA DEL MAULE ( Site 2768) Talca, Maule Region
UPMC Hillman Cancer Center ( Site 0008) Pittsburgh, Pennsylvania
UPR Comprehensive Cancer Center ( Site 1150) San Juan,
UZ Brussel ( Site 2900) Brussels, Bruxelles-Capitale, Region de
UZ Leuven ( Site 2901) Leuven, Vlaams-Brabant
UZ Leuven - Campus Gasthuisberg ( Site 2906) Leuven, Vlaams-Brabant
UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907) Leuven, Vlaams-Brabant
Udmurtian Republican Clinical Oncology Center ( Site 1212) Izhevsk, Udmurtiya Republic
Umraniye Training and Research Hospital ( Site 1329) Istanbul,
Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 1109) Chihuahua City,
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1750) Lisbon,
Uniklinikum Salzburg ( Site 2956) Salzburg,
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3492) Wuhan, Hubei
Universitaetsklinik Muenchen ( Site 2406) Munich, Bavaria
Universitaetsklinikum Essen ( Site 2404) Essen, North Rhine-Westphalia
Universitaetsklinikum Tuebingen ( Site 2405) Tübingen, Baden-Wurttemberg
Universitaetsklinikum des Saarlandes-Klinik für Innere Medizin V-Pneumologie, Allergologie, Beatmun ( Site 2411) Homburg, Saarland
Universitaetsspital Zuerich ( Site 0750) Zürich-Flughafen, Canton of Zurich
Universitair Medisch Centrum Groningen ( Site 1550) Groningen,
Universitatsklinikum Carl Gustav Carus ( Site 2407) Dresden, Saxony
University College London Hospital-Cancer Clinical Trials Unit ( Site 0520) London, London, City of
University Hospital Basel ( Site 0752) Basel, Canton of Basel-City
University Hospital Coventry & Warwickshire ( Site 0524) Coventry,
University Hospitals ( Site 0044) Cleveland, Ohio
University Malaya Medical Centre ( Site 0626) Kuala Lumpur,
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076) Orange, California
University of Colorado Cancer Center ( Site 0021) Aurora, Colorado
University of Iowa Hospital and Clinics ( Site 0026) Iowa City, Iowa
University of North Carolina at Chapel Hill ( Site 0040) Chapel Hill, North Carolina
University of Pennsylvania ( Site 0010) Philadelphia, Pennsylvania
University of Texas MD Anderson Cancer Center ( Site 0007) Houston, Texas
University of Tsukuba Hospital ( Site 3176) Tsukuba, Ibaraki
University of Virginia Health System ( Site 0035) Charlottesville, Virginia
University of the Ryukyus Hospital ( Site 3155) Ginowan, Okinawa
Universitätsklinikum Erlangen ( Site 2408) Erlangen, Bavaria
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 2909) Namur,
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 1607) Poznan, Greater Poland Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site 1622) Gdansk, Pomeranian Voivodeship
Uzhhorod City Multidisciplinary Clinical Hospital ( Site 3672) Uzhhorod, Zakarpattia Oblast
Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1413) Budapest,
VCU Health Adult Outpatient Pavillion ( Site 0080) Richmond, Virginia
Vall d´Hebron Gastric & Esophageal & Colorectal cancer therapeutic area ( Site 0889) Barcelona,
Vall d´Hebron Prostatic & Renal & Bladder cancer therapeutic area ( Site 0888) Barcelona,
Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060) Nashville, Tennessee
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0015) Nashville, Tennessee
Vejle Sygehus ( Site 0653) Vejle, Region Syddanmark
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300) Vilnius,
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 3301) Vilnius,
Volga District Medical Center Federal Medical and Biological Agency ( Site 1242) Nizhny Novgorod, Nizhny Novgorod Oblast
WCR Office ( Site 2002) Johannesburg, Gauteng
Waikato Hospital ( Site 1502) Hamilton, Waikato Region
Wakayama Medical University Hospital ( Site 3124) Wakayama,
WakeMed Cancer Care - Waverly Hematology & Medical Oncology ( Site 0074) Cary, North Carolina
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie ( Site 1623) Olsztyn, Warmian-Masurian Voivodeship
West Cancer Center and Research Institute ( Site 0055) Germantown, Tennessee
West China Hospital Sichuan University-respiratory ( Site 3473) Chengdu, Sichuan
Western General Hospital ( Site 0502) Edinburgh, Edinburgh, City of
Western Health-Sunshine & Footscray Hospitals ( Site 3023) St Albans, Victoria
Westmead Hospital ( Site 3000) Westmead, New South Wales
Weston Park Hospital ( Site 0519) Sheffield, England
White Plains Hospital-Center for Cancer Care ( Site 0069) White Plains, New York
Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1619) Poznan, Greater Poland Voivodeship
Wilgers Oncology Centre ( Site 2006) Pretoria, Gauteng
Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1606) Warsaw, Masovian Voivodeship
Women s Hospital School of Medicine Zhejiang University ( Site 3493) Hangzhou, Zhejiang
Women's Cancer Care ( Site 0088) Covington, Louisiana
Xiangya Hospital Central South University ( Site 3508) Changsha, Hunan
Xiangya Hospital Central South University-Gynecology ( Site 3497) Changsha, Hunan
Xiangya Hospital Central South University-Respiratory ( Site 3479) Changsha, Hunan
Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 3486) Ürümqi, Xinjiang
Yale Cancer Center ( Site 0014) New Haven, Connecticut
Yamaguchi University Hospital ( Site 3114) Ube, Yamaguchi
Yancheng First People s Hospital ( Site 3504) Yancheng, Jiangsu
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1243) Yaroslavl, Yaroslavl Oblast
Yokohama City University Hospital ( Site 3163) Yokohama, Kanagawa
Yokosuka Kyosai Hospital ( Site 3150) Yokosuka, Kanagawa
ZIV Medical Center-Hematology Institute ( Site 2061) Safed,
Zala Megyei Szent Rafael Korhaz ( Site 1400) Zalaegerszeg,
Zhejiang Cancer Hospital ( Site 3481) Hangzhou, Zhejiang
Zhejiang Cancer Hospital ( Site 3495) Hangzhou, Zhejiang
Zhongshan Hospital of Fudan University ( Site 3503) Shanghai, Shanghai Municipality
Zhytomyr Regional Oncology Center ( Site 3670) Zhytomyr, Zhytomyr Oblast
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969) Siena,

Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma

ctrrecruit@vcu.edu

NCT05112601
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Inclusion Criteria:
* Patients with measurable or non-measurable (detectable) recurrent endometrial cancer * Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI * Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions: * All other lesions (or sites of disease), including small lesions (longest diameter \<10 mm or pathological lymph nodes with \>= 10 to \< 15 mm short axis), are considered non-measurable disease * Ascites and/or pleural effusion attributed to tumor * Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions * Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing \[NGS\] panel) * Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results * Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.) * Patients may have received 1-2 prior lines of systemic therapy: * Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition * Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration * Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration * Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C) * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Platelets \>= 100,000/mcl * Absolute neutrophil count (ANC) \>= 1,500/mcl * Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) * Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\<3 x ULN may be enrolled) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN * Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \< grade 2 within 28 days prior to registration) * Thyroid-stimulating hormone (TSH) within normal limits (TSH \< ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated * Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery * As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval \< 450 msec * The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information * Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Exclusion Criteria:
* Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma * Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities * Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents * Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent * Patients on immunosuppressive therapy, with the exception of: * Intra-nasal, inhaled, topical or local steroid injections * Premedication for hypersensitivity reaction * Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease * Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody * Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women who are pregnant or unwilling to discontinue nursing * Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, BIOLOGICAL: Ipilimumab, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Endometrioid Adenocarcinoma, Recurrent Endometrial Carcinoma
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania Site Public Contact - (ClinicalResearchServices@upmc.edu)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Duke University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fred Hutchinson Cancer Center Seattle, Washington
Geauga Hospital Chardon, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio
Henrico Doctor's Hospital Richmond, Virginia
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
IRMC Cancer Center Indiana, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
IU Health North Hospital Carmel, Indiana
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Intermountain Health West End Clinic Billings, Montana
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Minnesota Oncology - Edina Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Nebraska Methodist Hospital Omaha, Nebraska
Northwest Cancer Center - Crown Point Crown Point, Indiana Site Public Contact - (CancerResearch@powershealth.org)
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Northwest Wisconsin Cancer Center Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Roswell Park Cancer Institute Buffalo, New York
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon
Saint Catherine Hospital Indianapolis, Indiana Site Public Contact - (Roster@nrgoncology.org)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Saint Vincent Frontier Cancer Center Billings, Montana
State University of New York Upstate Medical University Syracuse, New York
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The Community Hospital Munster, Indiana
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan
Trinity Health Muskegon Hospital Muskegon, Michigan
UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UHHS-Chagrin Highlands Medical Center Beachwood, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
UPMC Cancer Center at UPMC McKeesport McKeesport, Pennsylvania
UPMC Cancer Center at UPMC Northwest Seneca, Pennsylvania
UPMC Cancer Center-Natrona Heights Natrona Heights, Pennsylvania
UPMC Cancer Center-Washington Washington, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania Site Public Contact - (ClinicalResearchServices@upmc.edu)
UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center Erie Erie, Pennsylvania Site Public Contact - (ClinicalResearchServices@upmc.edu)
UPMC Hillman Cancer Center at Butler Health System Butler, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center in Coraopolis Moon Township, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC West Mifflin-Cancer Center Jefferson West Mifflin, Pennsylvania
UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania
UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania
UPMC-Mercy Hospital Pittsburgh, Pennsylvania
UPMC-Passavant Hospital Pittsburgh, Pennsylvania
UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania
UPMC-Saint Margaret Pittsburgh, Pennsylvania
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas Site Public Contact - (Suzanne.cole@utsouthwestern.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
University Cancer and Blood Center LLC Athens, Georgia
University Hospitals Parma Medical Center Parma, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Site Public Contact - (gingerreeves@uabmc.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Wilmot Cancer Institute at Webster Webster, New York Site Public Contact - (WCICTOresearch@urmc.rochester.edu)
Women and Infants Hospital Providence, Rhode Island
Women's Cancer Center of Nevada Las Vegas, Nevada
Women's Diagnostic Center - Munster Munster, Indiana Site Public Contact - (mnicholson@comhs.org)

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Study Director - clinicaltrials@beonemed.com

NCT06742996
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Inclusion Criteria:
* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) * Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis * Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator * Relapsed or refractory disease after the last line of therapy * Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function
Exclusion Criteria:
* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i) * Prior therapy with BTK degraders * Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible. * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug * Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug * Known central nervous system involvement by lymphoma * Clinically significant cardiovascular disease * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Sonrotoclax, DRUG: Zanubrutinib, DRUG: Placebo
Mantle Cell Lymphoma, B Cell Lymphoma
mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417
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Study Locations

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Location Contacts
Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken
Aidport Sp Z O O Skorzewo,
Antalya Memorial Hospital Dokuma,
Asan Medical Center Seoul, Seoul Teukbyeolsi
Atrium Health Levine Cancer Institute (Lci) Charlotte, North Carolina
Atrium Health Wake Forest Baptist Winston-Salem, North Carolina
Auxilio Mutuo Cancer Center San Juan,
Azienda Sanitaria Universitaria Giuliano Isontina Trieste,
Beatson West of Scotland Cancer Centre Glasgow, Lanarkshire
Beijing Cancer Hospital Beijing, Beijing Municipality
Birmingham Heartlands Hospital Birmingham,
Box Hill Hospital Box Hill,
Centre Hospitalier Universitaire Nantes Hotel Dieu Nantes,
Centroricerche Cliniche Di Verona Srl Verona,
Chiba Cancer Center Chiba, Chiba
Christchurch Hospital Christchurch,
Chu Hopital Lyon Sud PierreBenite,
Chu Montpellier Hopital Saint Eloi Montpellier,
Chu Tours Hopital Bretonneau Tours,
Clatterbridge Cancer Centre Liverpool,
Cleveland Clinic Florida Stuart, Florida
Cleveland Clinic Foundation Cleveland, Ohio
Dana Farber Cancer Institute Longwood Medical Center Boston, Massachusetts
Dept of Medicine Iii, University Hospitallmu München,
Derriford Hospital Plymouth,
Diakonie Klinikum Jung Stilling Krankenhaus Siegen,
Dokkyo Medical University Saitama Medical Center Saitama, Koshigaya,
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw,
Duke University Durham, North Carolina
Dunedin Hospital Dunedin,
Etlik City Hospital Ankara,
FUNDALEU Caba,
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana
Fudan University Shanghai Cancer Center Shanghai, Shanghai Municipality
Fundacao Pio Xii Hospital de Amor de Barretos Barretos,
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude Petrópolis,
GenesisCare North Shore St Leonards, New South Wales
H Puerta de Hierro Majadahonda Majadahonda,
Harbin Medical University Cancer Hospital Ha’erbin,
Hattiesburg Hematology and Oncology Clinic Hattiesburg, Mississippi
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular São Paulo,
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital Hiroshima, Hiroshima
Hokkaido University Hospital Hokkaido, Sapporo,
Hospital Aleman CABA,
Hospital Clinic de Barcelona Barcelona,
Hospital Do Cancer de Pernambuco Recife,
Hospital Erasto Gaertner Curitiba,
Hospital Felício Rocho Belo Horizonte,
Hospital Santa Rita de Cassia Afecc Vitória,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario de Cordoba Córdoba,
Hospital de Clínicas de Porto Alegre Porto Alegre,
Ico H Duran I Reynals Barcelona,
Institute of Science Tokyo Hospital Tokyo, Bunkyo-ku,
Instituto Joinvilense De Hematologia e Oncologia Joinville,
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst Meldola,
Jiangsu Province Hospital Nanjing, Jiangsu
Jiangxi Cancer Hospital Nanchang, Jiangxi
Kagoshima University Hospital Kagoshima, Kagoshima-ken
Kaiser Permanente Southern California Irvine, California
Kanagawa Cancer Center Yokohama,
Klinikum Chemnitz gGmbH Chemnitz,
Kobe City Medical Center General Hospital Kobe,
Kocaeli Universitesi Tip Fakultesi Kocaeli,
Kurashiki Central Hospital Okayama,
Liaoning Cancer Hospital and Institute Shenyang, Liaoning
Linear Clinical Research Nedlands, Western Australia
Linyi Cancer Hospital Linyi,
MD Anderson Cancer Center Houston, Texas
Matsuyama Red Cross Hospital Ehime,
Mayo Clinic Rochester Rochester, Minnesota
McGlinn Cancer Institute West Reading, Pennsylvania
Memorial Cancer Institute, Memorial Healthcare System Pembroke Pines, Florida
Memorial Sloan Kettering Cancer Center MSKCC New York, New York
Mission Cancer and Blood Waukee, Iowa
Monash Health Clayton, Victoria
Nanfang Hospital, Southern Medical University Guangzhou, Guangdong
National Hospital Organization Okayama Medical Center Okayama,
Nebraska Cancer Specialists Omaha, Nebraska
Nebraska Cancer Specialists St Francis Grand Island Grand Island, Nebraska
North Shore Hospital Auckland,
Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver, Washington
Ogaki Municipal Hospital Gifu, Ogaki,
Ohio Health Research Institute Columbus, Ohio
Ohio State University Comprehensive Cancer Center Columbus, Ohio
One Clinical Research Nedlands, Western Australia
Osaka Metropolitan University Hospital Osaka,
Osaka Red Cross Hospital Osakashi, Osaka
Ospedale Vito Fazzi, Asl Lecce Lecce,
Our Lady of the Lake Hospital Baton Rouge, Louisiana
Oxford University Hospitals Nhs Trust Churchill Hospital Headington,
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania
Perth Blood Institute West Perth, Western Australia
Policlinico Sorsola Malpighi, Aou Di Bologna Bologna,
Pratia MCM Kraków Krakow, Malopolska
Pusan National University Hospital Busan,
Rockingham Hospital Cooloongup, Western Australia
Rush University Medical Center Chicago, Illinois
Samsung Medical Center Seoul,
Seoul National University Bundang Hospital Seongnam,
Seoul National University Hospital Seoul,
Severance Hospital Yonsei University Health System SeodaemunGu, Seoul Teugbyeolsi
Shaanxi Provincial Peoples Hospital Xi'an, Shaanxi
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu, Sichuan
Stauferklinikum Schwabisch Gmund Kliniken Ostalb Mutlangen,
Sun Yat Sen University Cancer Center Guangzhou, Guangdong
Sunshine Coast Hospital and Health Service Birtinya, Queensland
Tauranga Hospital Tauranga,
Tennessee Oncology Nashville, Tennessee
Tennessee Oncology Nashville St Thomas Midtown Clinic Nashville, Tennessee
Texas Oncology Austin Midtown Round Rock, Texas
The Affiliated Hospital of Qingdao University Branch West Coast Qingdao, Shandong
The Affiliated Hospital of Xuzhou Medical University Xuzhou,
The Cancer and Hematology Centers Grand Rapids, Michigan
The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi
The Catholic University of Korea, Yeouido St Marys Hospital Yeongdeungpo-gu, Seoul Teugbyeolsi
The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Hangzhou, Zhejiang
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation Bournemouth,
The University of Maryland Greenebaum Comprehensive Cancer Center Baltimore, Maryland
The Valley Hospital, Inc Paramus, New Jersey
Tohoku University Hospital Sendai, Miyagi
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei
Toyohashi Municipal Hospital Toyohashishi, Aichi-ken
UCSF Fresno Fresno, California
Uk St Poelten Sankt Pölten,
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei
Universidade de Campinas Centro de Hematologia E Hemoterapia Campinas,
University College Hospital Ibadan,
University Hospitals Cleveland, Ohio
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of Arizona Cancer Center Tucson, Arizona
University of Chicago Medical Center Chicago, Illinois
University of Michigan Ann Arbor, Michigan
University of Virginia Charlottesville, Virginia
University of Wisconsin Madison, Wisconsin
Universitätsklinikum Frankfurt Frankfurt,
Universitätsklinikum Halle Halle, Saxony-Anhalt
Universitätsklinikum Hamburg Eppendorf Hamburg,
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Lublin,
VCU Massey Cancer Center Richmond, Virginia
Virgina Cancer Specialists Gainesville, Virginia
Washington University School of Medicine St Louis, Missouri
Wellington Regional Hospital (Ccdhb) Wellington,
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz,
Yale University Yale Cancer Center New Haven, Connecticut
Yokohama Municipal Citizens Hospital Yokohama,
hospital Italiano de Buenos Aires CABA,

EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)

NSABP Department of Site and Study Management Department of Site and Study Management - industry.trials@nsabp.org

NCT06401421
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Inclusion Criteria:

• The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
• The participant must be ≥ 18 years of age.
• ECOG performance status 0 or 1.
• Histologically confirmed invasive carcinoma of the breast.
• Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
• Tumor size ≥ 2.1 cm in greatest diameter.
• Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
• Clinically node positive or if node negative, any one of the following:
• TNBC or HER2+ subtype
• HR+/HER2-negative with at least one of the following: i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.)
• Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
• Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
Exclusion Criteria:

• Definitive clinical or radiologic evidence of metastatic disease.
• Initiated neoadjuvant therapy for current breast cancer diagnosis.
• Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
• Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
• Completed all therapy for any previous hematologic malignancy \< 5 years ago.
• Multicentric or contralateral invasive breast cancers.
• Known pregnancy at time of enrollment.
• Prior solid organ transplant.
• Prior allogeneic hematopoietic stem cell transplant.
DIAGNOSTIC_TEST: ctDNA MRD test
Breast Cancer
Breast Cancer, ctDNA
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Study Locations

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Location Contacts
AdventHealth East Altamonte Oncology and Hematology Altamonte Springs, Florida
Alan B. Pearson Regional Cancer Center Lynchburg, Virginia
Atrium Health Levine Cancer Institute Charlotte, North Carolina
Atrium Health Wake Forest Baptist Medical Center Winston-Salem, North Carolina
Aultman Timken Family Cancer Center Canton, Ohio
Aurora Cancer Care - Wauwatosa Wauwatosa, Wisconsin
Avera Cancer Institute Sioux Falls, South Dakota
Ballad Health Cancer Center Kingsport, Tennessee
Baptist Cancer Care - Plantation Plantation, Florida
Baptist Health Louisville Louisville, Kentucky
Bon Secours Cancer Institute at St. Francis Midlothian, Virginia
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Cleveland Clinic Main Campus Cleveland, Ohio
Deaconess Chancellor Center for Oncology Newburgh, Indiana
FirstHealth Outpatient Cancer Center Pinehurst, North Carolina
Greater Baltimore Medical Center Baltimore, Maryland
Guthrie Sayre Sayre, Pennsylvania
Harbor-UCLA Medical Center - Hematology / Oncology Torrance, California
Holy Cross Hospital - Silver Spring Silver Spring, Maryland
Hôpital du Saint-Sacrement Québec, Quebec
James M Stockman Cancer Institute Frederick, Maryland
Jewish General Hospital Montreal, Quebec
Joe Arrington Cancer Research & Treatment Center Lubbock, Texas
John Theurer Cancer Center Hackensack, New Jersey
Kaiser Permanente Medical Center Riverside, California
Katmai Oncology Group - Anchorage Anchorage, Alaska
Lahey Hospital & Medical Center Burlington, Massachusetts
Maisonneuve-Rosemont Hospital (HMR) Montreal, Quebec
McGill University Health - Glen Site Montreal, Quebec
MedStar Georgetown Cancer Institute Baltimore, Maryland
Meritus Center for Clinical Research Hagerstown, Maryland
Metro Minnesota Community Oncology Consortium (MMCORC) Saint Louis Park, Minnesota
Mount Sinai Medical - Comprehensive Cancer Center Miami Beach, Florida
Norton Cancer Institute - Downtown Louisville, Kentucky
Novant Health Cancer Institute - Elizabeth Charlotte, North Carolina
Penn State Cancer Institute Hershey, Pennsylvania
Penn State Health Medical Group - Andrews Patel Harrisburg, Pennsylvania
Rush Cancer Center Chicago, Illinois
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Saint Luke's Hospital of Kansas City Kansas City, Missouri
Sinai Hospital of Baltimore Baltimore, Maryland
Spartanburg Medical Center Spartanburg, South Carolina
St. Elizabeth Edgewood Hospital Edgewood, Kentucky
St. Joseph'S Women'S Hospital Tampa, Florida
Stanford Cancer Institute Stanford, California
Stony Brook Medicine Stony Brook, New York
Tate Cancer Center at UM Baltimore Washington Glen Burnie, Maryland
The Center for Cancer and Blood Disorders - Bethesda Bethesda, Maryland
The University of Texas MD Anderson Cancer Center Houston, Texas
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora, Colorado
UNC Cancer Care at Nash Rocky Mount, North Carolina
UPMC Magee - Womens Hospital Pittsburgh, Pennsylvania
University of Kansas Cancer Center Kansas City, Kansas
University of Maryland St. Joseph Medical Center Towson, Maryland
VCU Massey Comprehensive Cancer Center Richmond, Virginia
WVU Cancer Institute Morgantown, West Virginia
Weinberg Center at Mercy Baltimore, Maryland
Women & Infants Hospital Providence, Rhode Island

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

ctrrecruit@vcu.edu

NCT04269902
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Inclusion Criteria:
* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration * Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities) * Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p * TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p) * Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed * Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration) * Serum beta-2 microglobulin level must be obtained within 28 days prior to registration * Participants must not meet any of the IWCLL specified criteria for active CLL therapy * Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment * Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration * Prior therapy with anti CD20 monoclonal antibodies is not allowed * Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 \[COVID-19\]), or radiotherapy * Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy * Participants must be \>= 18 years of age * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Platelet count \>= 100,000/mm\^3 within 28 days prior to registration * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration * Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration * Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration * Participants must be able to take oral medications * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy * Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor * Participants must not have cirrhosis * Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O. * Active infection with hepatitis B or C: * Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR). * Latent infection with hepatitis B: * Latent infection is defined as meeting all of the following criteria: * Hepatitis B surface antigen positive * Anti-hepatitis B total core antibody positive * Anti-hepatitis IgM core antibody undetectable * Hepatitis B PCR undetectable * Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O. * Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis * Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair * Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia) * Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment * Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5 * Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura * Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification * Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment * Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Participants must agree to have specimens submitted for translational medicine (MRD) as outlined * Participants must be offered the opportunity to participate in specimen banking for future research as outlined. * NOTE: With participant's consent, the site must follow through with specimen submission as outlined * Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.) * Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Obinutuzumab, OTHER: Questionnaire Administration, DRUG: Venetoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota
Adena Regional Medical Center Chillicothe, Ohio
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Alaska Breast Care and Surgery LLC Anchorage, Alaska
Alaska Oncology and Hematology LLC Anchorage, Alaska
Alaska Women's Cancer Care Anchorage, Alaska
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska
Alegent Health Immanuel Medical Center Omaha, Nebraska
Alegent Health Lakeside Hospital Omaha, Nebraska
Alegent Health Mercy Hospital Council Bluffs, Iowa
Allan Blair Cancer Centre Regina, Saskatchewan
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Armes Family Cancer Center Findlay, Ohio
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care-Wausau Wausau, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio
BCCA-Vancouver Cancer Centre Vancouver, British Columbia
Ballad Health Cancer Care - Bristol Bristol, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Norton Norton, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Banner North Colorado Medical Center Greeley, Colorado
Banner North Colorado Medical Center - Loveland Campus Loveland, Colorado
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Hospital Coos Bay, Oregon
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Beebe Health Campus Rehoboth Beach, Delaware Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware
Beebe South Coastal Health Campus Millville, Delaware Site Public Contact - (research@beebehealthcare.org)
Bellin Memorial Hospital Green Bay, Wisconsin
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming
Blanchard Valley Hospital Findlay, Ohio
Boulder Community Foothills Hospital Boulder, Colorado
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bristol Regional Medical Center Bristol, Tennessee
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CHI Health Good Samaritan Kearney, Nebraska
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
Cambridge Medical Center Cambridge, Minnesota
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona
Cancer Center of Colorado at Sloan's Lake Denver, Colorado
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer Partners of Nebraska Lincoln, Nebraska
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan
Central Care Cancer Center - Bolivar Bolivar, Missouri
Central Care Cancer Center - Garden City Garden City, Kansas
Central Care Cancer Center - Great Bend Great Bend, Kansas
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio
Centralia Oncology Clinic Centralia, Illinois
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Cheyenne Regional Medical Center-West Cheyenne, Wyoming
Christiana Care Health System-Christiana Hospital Newark, Delaware
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware
City of Hope Antelope Valley Lancaster, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Newport Beach Newport Beach, California
City of Hope Seacliff Huntington Beach, California
City of Hope South Bay Torrance, California
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
City of Hope at Long Beach Elm Long Beach, California
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Mercy Hospital Canton, Ohio
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Colorado Blood Cancer Institute Denver, Colorado
Columbus Oncology and Hematology Associates Inc Columbus, Ohio
CommonSpirit Cancer Center Mercy Durango, Colorado
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado
CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky
CommonSpirit Saint Joseph Hospital London London, Kentucky
CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky
Commonwealth Cancer Center-Corbin Corbin, Kentucky
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Dayton Physicians LLC-Wayne Greenville, Ohio
Decatur Memorial Hospital Decatur, Illinois
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio
Doctors Hospital Columbus, Ohio
Dublin Methodist Hospital Dublin, Ohio
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Durham VA Medical Center Durham, North Carolina
ECU Health Oncology Kenansville Kenansville, North Carolina
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Enloe Medical Center Chico, California
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
FHCC Overlake Bellevue, Washington
FHCC at EvergreenHealth Kirkland, Washington
FHCC at Northwest Hospital Seattle, Washington
Fairbanks Memorial Hospital Fairbanks, Alaska
Fairfield Medical Center Lancaster, Ohio
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota
Fairview Lakes Medical Center Wyoming, Minnesota
Fairview Northland Medical Center Princeton, Minnesota
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Fred Hutchinson Cancer Center Seattle, Washington
Freeman Health System Joplin, Missouri
Fremont - Rideout Cancer Center Marysville, California
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan
Genesis Healthcare System Cancer Care Center Zanesville, Ohio
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio
Grady Memorial Hospital Delaware, Ohio
Grand Valley Oncology Grand Junction, Colorado Site Public Contact - (gvoclinicaltrials@gjhosp.org)
Grant Medical Center Columbus, Ohio
Great Falls Clinic Great Falls, Montana
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa
Gundersen Lutheran Medical Center La Crosse, Wisconsin
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
Harold Alfond Center for Cancer Care Augusta, Maine
Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington
HaysMed Hays, Kansas
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-Auburn Auburn, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hematology/Oncology Clinic PLLC Baton Rouge, Louisiana
Hennepin County Medical Center Minneapolis, Minnesota
Henry Ford Cancer Institute-Downriver Brownstown, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Health Providence Novi Hospital Novi, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Health Providence Southfield Hospital Southfield, Michigan
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Health Center - Shelby Township Shelby, Michigan
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Fairlane Dearborn, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford River District Hospital East China Township, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan
Henry Ford Warren Hospital - GLCMS Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Wyandotte Hospital Wyandotte, Michigan Site Public Contact - (nhay@hfhs.org)
Hickman Cancer Center Adrian, Michigan
Highline Medical Center-Main Campus Burien, Washington
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan
Hope Cancer Clinic Livonia, Michigan
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Idaho Urologic Institute-Meridian Meridian, Idaho
Illinois CancerCare - Washington Washington, Illinois
Illinois CancerCare-Bloomington Bloomington, Illinois
Illinois CancerCare-Canton Canton, Illinois
Illinois CancerCare-Carthage Carthage, Illinois
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois
Illinois CancerCare-Galesburg Galesburg, Illinois
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois
Illinois CancerCare-Macomb Macomb, Illinois
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois
Illinois CancerCare-Pekin Pekin, Illinois
Illinois CancerCare-Peoria Peoria, Illinois
Illinois CancerCare-Peru Peru, Illinois
Illinois CancerCare-Princeton Princeton, Illinois
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Healthcare Port Townsend, Washington
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Jersey City Medical Center Jersey City, New Jersey Site Public Contact - (ctsucontact@westat.com)
Jewish General Hospital Montreal, Quebec
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Kansas City Veterans Affairs Medical Center Kansas City, Missouri
Katmai Oncology Group Anchorage, Alaska
Kettering Medical Center Kettering, Ohio
Knox Community Hospital Mount Vernon, Ohio
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana
Lakeridge Health Oshawa Oshawa, Ontario
Lakeview Hospital Stillwater, Minnesota
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania
Licking Memorial Hospital Newark, Ohio
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Longmont United Hospital Longmont, Colorado
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth LincolnHealth Hospital Damariscotta, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina Site Public Contact - (pardeecancerresearch@unchealth.unc.edu)
Marietta Memorial Hospital Marietta, Ohio
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshall Cancer Center Cameron Park, California Site Public Contact - (cancerservices@marshallmedical.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital Marysville, Ohio
Memorial Hospital of Carbondale Carbondale, Illinois
Memorial Medical Center-Las Cruces Las Cruces, New Mexico Site Public Contact - (Deborah.Brown@LPNT.net)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California
Mercy Cancer Center - Elk Grove Elk Grove, California
Mercy Cancer Center - Rocklin Rocklin, California
Mercy Cancer Center - Sacramento Sacramento, California
Mercy Cancer Center-West Lakes Clive, Iowa
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Perrysburg Hospital Perrysburg, Ohio
Mercy Health - Saint Anne Hospital Toledo, Ohio
Mercy Health - Saint Vincent Hospital Toledo, Ohio
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Medical Center Springfield, Massachusetts
Mercy Medical Center - Des Moines Des Moines, Iowa
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California
Methodist Medical Center of Illinois Peoria, Illinois
Methodist West Hospital West Des Moines, Iowa
Miami Valley Hospital Dayton, Ohio
Miami Valley Hospital North Dayton, Ohio
Miami Valley Hospital South Centerville, Ohio
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Mid Coast Hospital Brunswick, Maine Site Public Contact - (ctsucontact@westat.com)
Midlands Community Hospital Papillion, Nebraska
Minneapolis VA Medical Center Minneapolis, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California
Mission Hope Medical Oncology - Santa Maria Santa Maria, California
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monmouth Medical Center Southern Campus Lakewood, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monticello Cancer Center Monticello, Minnesota
Mount Carmel East Hospital Columbus, Ohio
Mount Carmel Grove City Hospital Grove City, Ohio
Mount Carmel Health Center West Columbus, Ohio
Mount Sinai Hospital New York, New York
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas Site Public Contact - (Emily.Carvell@bmhcc.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
National Jewish Health-Main Campus Denver, Colorado
National Jewish Health-Northern Hematology Oncology Thornton, Colorado
National Jewish Health-Western Hematology Oncology Golden, Colorado
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
New Ulm Medical Center New Ulm, Minnesota
Newark Radiation Oncology Newark, Ohio
Newland Medical Associates-Clarkston Clarkston, Michigan
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
North Memorial Medical Health Center Robbinsdale, Minnesota
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwest Medical Specialties PLLC Tacoma, Washington
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
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OSF Saint Anthony's Health Center Alton, Illinois
Ochsner LSU Health Monroe Medical Center Monroe, Louisiana
Ochsner LSU Health Saint Mary's Medical Center Shreveport, Louisiana
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio
OhioHealth Marion General Hospital Marion, Ohio
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio
OptumCare Cancer Care at Charleston Las Vegas, Nevada
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada
Orion Cancer Care Findlay, Ohio
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California
Pacific Gynecology Specialists Seattle, Washington
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint John Medical Center Longview, Washington
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth Southwest Medical Center Vancouver, Washington
PeaceHealth United General Medical Center Sedro-Woolley, Washington
Penrose-Saint Francis Healthcare Colorado Springs, Colorado
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Physicians' Clinic of Iowa PC Cedar Rapids, Iowa
Pocono Medical Center East Stroudsburg, Pennsylvania
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado
Presbyterian Kaseman Hospital Albuquerque, New Mexico
Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico Site Public Contact - (WBurman@phs.org)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Regional Cancer Partnership Everett, Washington
Providence Regional Cancer System-Aberdeen Aberdeen, Washington
Providence Regional Cancer System-Centralia Centralia, Washington
Providence Regional Cancer System-Lacey Lacey, Washington
Providence Regional Cancer System-Shelton Shelton, Washington
Providence Regional Cancer System-Yelm Yelm, Washington
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California
Providence Saint Mary Regional Cancer Center Walla Walla, Washington
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia
Ralph H Johnson VA Medical Center Charleston, South Carolina Site Public Contact - (ashley.salvo@va.gov)
Regions Hospital Saint Paul, Minnesota
Reid Health Richmond, Indiana
Rice Memorial Hospital Willmar, Minnesota
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Riverside Methodist Hospital Columbus, Ohio
Rochester General Hospital Rochester, New York
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Rose Medical Center Denver, Colorado
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Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SIH Cancer Institute Carterville, Illinois
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STCC at DHR Health Institute for Research and Development Edinburg, Texas
SUNY Upstate Medical Center-Community Campus Syracuse, New York
Sacred Heart Hospital Pensacola, Florida
Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon
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Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Ann's Hospital Westerville, Ohio
Saint Anthony Regional Hospital Carroll, Iowa
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Saint Charles Health System-Redmond Redmond, Oregon
Saint Clare Hospital Lakewood, Washington
Saint Elizabeth Boardman Hospital Boardman, Ohio
Saint Elizabeth Hospital Enumclaw, Washington
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio
Saint Francis Hospital Greenville, South Carolina
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Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado
Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington
Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky
Saint Joseph Regional Cancer Center Bryan, Texas
Saint Joseph Warren Hospital Warren, Ohio
Saint Luke's Cancer Institute - Boise Boise, Idaho
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho
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Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho
Saint Luke's Hospital Chesterfield, Missouri
Saint Mary Corwin Medical Center Pueblo, Colorado
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado
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Saint Patrick Hospital - Community Hospital Missoula, Montana
Saint Rita's Medical Center Lima, Ohio
Saint Vincent Frontier Cancer Center Billings, Montana
Saint Vincent Healthcare Billings, Montana
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin
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Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Saints Mary and Elizabeth Hospital Louisville, Kentucky
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Sibley Memorial Hospital Washington D.C., District of Columbia Site Public Contact - (jquiver1@jhmi.edu)
Siteman Cancer Center at Christian Hospital St Louis, Missouri
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri
Siteman Cancer Center-South County St Louis, Missouri
Sky Ridge Medical Center Lone Tree, Colorado
Southeastern Medical Oncology Center-Clinton Clinton, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ohio Medical Center Portsmouth, Ohio
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois
Springfield Regional Cancer Center Springfield, Ohio
Springfield Regional Medical Center Springfield, Ohio
Stanford Cancer Institute Palo Alto Palo Alto, California
State University of New York Upstate Medical University Syracuse, New York
Strecker Cancer Center-Belpre Belpre, Ohio
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center Englewood, Colorado
Swedish Medical Center-Ballard Campus Seattle, Washington
Swedish Medical Center-Cherry Hill Seattle, Washington
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The Carle Foundation Hospital Urbana, Illinois
The Mark H Zangmeister Center Columbus, Ohio
The Medical Center of Aurora Aurora, Colorado
The Melanoma and Skin Cancer Institute Englewood, Colorado
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
The Women's Imaging Center Denver, Colorado
ThedaCare Regional Cancer Center Appleton, Wisconsin
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Tibor Rubin VA Medical Center Long Beach, California
TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware
Toledo Clinic Cancer Centers-Monroe Monroe, Michigan
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio
TriHealth Cancer Institute-Anderson Cincinnati, Ohio
TriHealth Cancer Institute-Westside Cincinnati, Ohio
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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Trinity Health Muskegon Hospital Muskegon, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts Site Public Contact - (NCCCR@Tuftsmedicalcenter.org)
Tulane University School of Medicine New Orleans, Louisiana
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UC Irvine Health Cancer Center-Newport Costa Mesa, California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UCI Health Laguna Hills Laguna Hills, California Site Public Contact - (ucstudy@uci.edu)
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas
UW Health Carbone Cancer Center Rockford Rockford, Illinois Site Public Contact - (lkline@uwhealth.org)
United Hospital Saint Paul, Minnesota
Unity Hospital Fridley, Minnesota
University Health Truman Medical Center Kansas City, Missouri
University of Alabama at Birmingham Cancer Center Birmingham, Alabama
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Chicago Medicine-Orland Park Orland Park, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio
University of Cincinnati Cancer Center-West Chester West Chester, Ohio
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - Briarcliff Kansas City, Missouri
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University of Kansas Health System Saint Francis Campus Topeka, Kansas
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of New Mexico Cancer Center Albuquerque, New Mexico
University of North Carolina-Hillsborough Campus Hillsborough, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Washington Medical Center - Montlake Seattle, Washington
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
UofL Health Medical Center Northeast Louisville, Kentucky
Upper Valley Medical Center Troy, Ohio
Upstate Cancer Center at Oswego Oswego, New York Site Public Contact - (McDowelE@upstate.edu)
Upstate Cancer Center at Verona Verona, New York Site Public Contact - (McDowelE@upstate.edu)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Radiation Oncology Peru, Illinois
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Walter Knox Memorial Hospital Emmett, Idaho
Walter Reed National Military Medical Center Bethesda, Maryland
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Wayne Hospital Greenville, Ohio
Welch Cancer Center Sheridan, Wyoming
Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Western Illinois Cancer Treatment Center Galesburg, Illinois
Western Surgical Care Denver, Colorado
Wilmot Cancer Institute at Webster Webster, New York Site Public Contact - (WCICTOresearch@urmc.rochester.edu)
Woodland Memorial Hospital Woodland, California
Wright-Patterson Medical Center Wright-Patterson Air Force Base, Ohio
Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin

Pancreatic Cancer Early Detection Consortium (PRECEDE)

Naveen Fawas, BS - naveen.fawaz@arborresearch.org

NCT04970056
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Inclusion Criteria:
Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database: Cohort 1 Individuals without history of PDAC meeting any of the following criteria:
• 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
• Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
• Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+ Cohort 2 Individuals without history of PDAC meeting any of the following criteria:
• ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
• 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
• 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2) Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort. Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort. Cohort 6a Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 Cohort 6b Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45 Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b. Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c. Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Exclusion Criteria:
* Individuals not meeting the criteria above.
Pancreas Cancer, Pancreas Cyst, Pancreatic Ductal Adenocarcinoma, Genetic Predisposition
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Study Locations

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Location Contacts
Azienda Ospedaliera Universitaria Integrata Verona Verona, Salvatore Paiella - (salvatore.paiella@univr.it) Erica Secchettin - (erica.secchettin@univr.it)
Beaumont/Corewell Health Royal Oak, Michigan Tara Rangarajan - (tara.rangarajan@corewellhealth.org)
British Columbia Cancer Agency Vancouver, British Columbia Eugene Cheung - (eugene.cheung1@bccancer.bc.ca)
Cedars-Sinai Medical Center Los Angeles, California Jenny Frisendahl - (jenny.frisendahl@cshs.org)
City of Hope Duarte, California Diamond Ward - (diward@coh.org)
Columbia University Irving Medical Center New York, New York Katharine Godfrey - (kb3217@cumc.columbia.edu)
Emory University Hospital Atlanta, Georgia Halley Fowler - (halley.fowler@emory.edu)
Epworth Healthcare Richmond, Victoria Ashleigh Poh - (ashleigh.poh@epworth.org.au)
Fox Chase Cancer Center Philadelphia, Pennsylvania Eberechukwu Muoneke - (eberechukwu.muoneke@fccc.edu)
Hackensack Meridian Health Hackensack, New Jersey Christianna Torres - (christianna.torres@hmhn.org)
Hoag Newport Beach, California Alexandria Adams - (alexandria.adams@hoag.org) Zulma Loera - (zulma.loera@hoag.org)
Honor Health Research Institute Scottsdale, Arizona Jeanette Dupree - (jdupree@honorhealth.com)
Hospital Clinic de Barcelona Barcelona, Eva Vaquero - (evaquero@clinic.cat)
Hospital Universitari Arnau de Vilanova Lleida, Lerida Xavier Molero - (xmolero@gss.cat)
Huntsman Cancer Institute Salt Lake City, Utah Jo Lyman - (jo.anson@hci.utah.edu)
Icahn School of Medicine at Mount Sinai New York, New York Joyce Serebrenik - (joyce.serebrenik@mountsinai.org) Storey Harbison - (storey.harbison@mssm.edu)
Illinois CancerCare Peoria, Illinois Carrie Geoffroy - (cgeoffroy@illinoiscancercare.com)
Inova Schar Cancer Institute Fairfax, Virginia Salman Baig - (Salman.Baig@inova.org)
Intermountain Health Salt Lake City, Utah
Landspitali University Hospital Reykjavik, Jóhanna Stefansdottir - (johanste@landspitali.is)
MD Anderson Center Houston, Texas
Massachusetts General Hospital Lexington, Massachusetts Danielle Lynch - (dlynch22@mgh.harvard.edu)
Mayo Clinic Arizona Phoenix, Arizona Michele Richardson - (richardson.michele@mayo.edu)
Mayo Clinic Jacksonville Jacksonville, Florida Christian Glover - (glover.christian@mayo.edu)
McGill University Health Centre Montreal, Quebec Adeline Cuggia - (pancreas.surveillance@muhc.mcgill.ca)
Memorial Sloan Kettering Cancer Center New York, New York Jeffin Naduparambil - (naduparj@mskcc.org)
Moffitt Cancer Center Tampa, Florida Toni Basinski - (Toni.Basinski@Moffitt.Org)
National Cancer Centre Singapore Singapore, Caitlin Nicole - (caitlin.nicole.s.v@nccs.com.sg) Meggie Huang Mochao - (meggie.huang.m.c@nccs.com.sg)
National Cheng Kung University Hospital (NCKUH) Tainan, Taiwan T.o.c. Yung-Yeh Su - (yysu@nhri.edu.tw)
National Taiwan University Hospital Taipei, Wei-Chih David Liao - (david.ntuh@gmail.com)
NorthShore University Healthsystem Evanston, Illinois Aram Rojas - (arojas@northshore.org)
Oregon Health & Science University Portland, Oregon Dove Keith - (keithd@ohsu.edu)
Providence Health and Services Burbank, California Taridu Ekanayake - (emtaridu.ekanayake@providence.org)
Ramón y Cajal University Hospital Madrid, Julie Earl - (julie.earl@live.co.uk)
Semmelweis University, Institute of Pancreatic Diseases Budapest, Zoltán Hajnády - (hajnady.zoltan@semmelweis.hu)
Sheba Medical Center Ramat Gan, Maria Raitses - (Maria.RaitsesGurevich@sheba.health.gov.il)
The Ohio State University Columbus, Ohio Ashley Tyson - (Ashley.Tyson@osumc.edu)
The University of Texas Southwestern Medical Center Dallas, Texas
UC Davis Sacramento, California Tanpreet Dodd - (tkdodd@health.ucdavis.edu)
UC Irvine Health Orange, California Blake Johnson - (blakej@hs.uci.edu)
UC San Diego Moores Cancer Center La Jolla, California Emma Vail - (e2brooks@health.ucsd.edu)
UCLA Health Los Angeles, California Sophia Quiroz - (SStokes@mednet.ucla.edu)
UMass Memorial Medical Center Worcester, Massachusetts Paige Malone - (paige.malone@umassmed.edu)
University Health Network Toronto, Ontario Spring Holter - (spring.holter@uhn.ca)
University of California, San Francisco (UCSF) San Francisco, California Kurt Giles - (PancreasCRC@ucsf.edu)
University of Chicago Medicine Chicago, Illinois Nia Howard - (nia.howard@bsd.uchicago.edu)
University of Kansas Medical Center Kansas City, Kansas Jodi Claybaugh - (jclaybaugh@kumc.edu)
University of Liverpool Liverpool, Annabelle Boughey - (europac@liverpool.ac.uk)
University of Miami Miami, Florida Casper Ruiz Ruiz - (cxr1353@med.miami.edu)
University of Michigan Ann Arbor, Michigan Sarah Volk - (stomanic@med.umich.edu) Erika Koeppe - (eskoeppe@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Suzanne Wessling - (suzanne.wessling@unmc.edu)
University of Pennsylvania Philadelphia, Pennsylvania Danny Clay - (Daniel.Clay@Pennmedicine.upenn.edu)
University of Pittsburgh Medical Center (UPMC) Pittsburgh, Pennsylvania Beth Dudley - (dudleyre@upmc.edu)
University of Rochester Medical Center Rochester, New York Chelsea DiBella - (chelsea_dibella@urmc.rochester.edu)
University of Tennessee Graduate School of Medicine Knoxville, Tennessee Tiffany Johnson - (thjohnson@utmck.edu)
University of Virginia Charlottesville, Virginia Evelyn Garcia - (ev4pd@uvahealth.org)
University of Washington Seattle, Washington Lisa Ann Lai - (lail@uw.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Faith McFadden - (mcfaddenfr@vcu.edu)
White Plains Hospital White Plains, New York Griselda Cruz - (grcruz@wphospital.org)
Yale University New Haven, Connecticut Scott Merenda - (scott.merenda@yale.edu)

Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

Massey IIT Research Operations - masseyepd@vcu.edu

NCT06966388
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Inclusion Criteria:
Age ≥ 18 years * Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18) * Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period * Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy * Treatment plan includes one of the following: * Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions) * Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions) * Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions) * Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface * Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician. * Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician.
Exclusion Criteria:
* Prior radiotherapy to any portion of the planned treatment site * Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy * Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed * Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field * Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis) * History of organ transplant or bone marrow transplant * History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation * Has used within 28 days prior to baseline: * topical retinoids to the breast * oral retinoids * systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim) * systemic corticosteroids or immunosuppressive drugs, except as part of standard chemotherapy treatment or used for an IV contrast allergy * Has used on treated breast within 2 weeks prior to baseline: * topical corticosteroids * topical antibiotics * topical medications for skin rash (eg, metronidazole, azelaic acid) * Radiation therapy will be proton therapy or carbon therapy * External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
DRUG: Azelaic Acid
Breast Cancer
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Study Locations

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Location Contacts
Virginia Commonwealth University Richmond, Virginia Massey CTO CPC Team - (MasseyCPC@vcu.edu)