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36 Study Matches

Myocardial Ischemia and Transfusion (MINT)

Jeffrey L Carson, MD - Jeffrey.Carson@Rutgers.edu

Kontos, Michael, C
NCT02981407
HM20010218
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Inclusion Criteria:

• 18 years of age or older
• Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
• Hemoglobin concentration less than 10 g/dL at the time of random allocation
• Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Exclusion Criteria:

• Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
• Decline blood transfusion
• Scheduled for cardiac surgery during the current admission
• Receiving only palliative treatment
• Known that follow-up will not be possible at 30 days
• Previously participated in MINT
• Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
• Patient physician does not believe the patient is an appropriate candidate for the trial
Biological: Red Blood Cell Transfusion
Myocardial Infarction, Anemia
Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
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Study Locations

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Location Contacts
AMITA Health Hinsdale, Illinois
Albany Medical College Albany, New York
Alexian Brothers Medical Center Elk Grove Village, Illinois
Auckland City Hospital Auckland,
Aultman Hospital Canton, Ohio Jeannie Archinai
Baylor St Luke's Medical Center Houston, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Boston Medical Center Boston, Massachusetts
CH Chartres - Chartres Chartres,
CHRU Tours -Hôpital Trousseau Chambray-lès-Tours,
CHU Arnaud de Villeneuve - Montpellier Montpellier,
CHU Nancy Nancy,
CHU Poitiers - Poitiers Poitiers,
CHU le Bocage - Dijon Dijon,
Central Arkansas Veterans Healthcare System Little Rock, Arkansas
Centre Hosp. Universitaire de Montréal Montréal, Quebec
Centre Hospitalier Sud Francilien Corbeil-Essonnes,
Centre Hospitalier Universitaire de Lille Lille,
Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, Quebec
Christchurch Hospital Christchurch,
Concord Repatriation General Hospital Concord, New South Wales
Copper University Hospital Camden, New Jersey
Danbury Hospital Danbury, Connecticut
Durham Va Durham, North Carolina
Essentia Health Duluth, Minnesota
Flinders Medical Centre Bedford Park,
Foothills Medical Centre Calgary,
General Hospital Trois-Rivièrs Trois-Rivières, Quebec
Gisborne Hospital Gisborne,
Gosford Hospital Gosford,
Greenville Health System Greenville, South Carolina
Grey Nuns Community Hospital Edmonton, Alberta
Hackensacjk University Medical Center Hackensack, New Jersey
Hamilton Health Sciences Hamilton, Ontario
Hamilton St. Joseph's Health Hamilton, Ontario
Hopital Charles LeMoyne Greenfield Park, Quebec
Hopital Europeen Georges-Pompidou Paris,
Hopital Haut Leveque Pessac,
Hopital La Pitie Salpetriere Paris,
Hopital Pasteur Nice,
Hopital Rangueil Toulouse,
Hospital Agamenon Magalhães Recife, Pernambuco
Hospital Cárdio Pulmonar Salvador, Bahia
Hospital Felício Rocho Belo Horizonte,
Hospital Maternidade e Pronto Socorro Santa Lucia Poços de Caldas, Minas Gerais
Hospital São Paulo São Paulo,
Hospital Universitário Professor Edgard Santos Salvador,
Hospital Vera Cruz Campinas,
Hospital das Clinicas da UFU Uberlândia,
Hospital de Base de Rio Preto São José Do Rio Preto, São Paulo
Hospital de Base de Rio Preto São José Do Rio Preto, São Paulo
Hospital de Clínicas da UFTM Uberaba,
Hotel-Dieu de Levis Lévis, Quebec
Hôpital BICHAT- APHP Paris,
Hôpital Charles Nicolle- Rouen Rouen,
Hôpital Lariboisière Paris,
Hôpital Universitaire Carémeau (CHU Carémeau) Nîmes,
Instituto Orizonti Belo Horizonte,
Instituto de Cardiologia do RS Porto Alegre,
Instituto de Ensino e Pesquisa do Hospital da Bahia Salvador, Estado de Bahia
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil Brasília,
Jersey Shore University Medical Neptune, New Jersey
Jewish General Hospital Montreal, Quebec
La Tronche Hôpital Michallon La Tronche,
Lahey Hospital Burlington, Massachusetts
Lancaster General Hospital Lancaster, Pennsylvania
Lankenau Medical Center Wynnewood, Pennsylvania
Lenox Hilll Hospital New York, New York
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Medical College of Wisconsin - Froedtert Hospital Milwaukee, Wisconsin Barbara Shimada-Krouwer, RN BSB
Memorial Hospital at Gulfport Gulfport, Mississippi
Minneapolis Heart Institute (Foundation) Minneapolis, Minnesota
Montefiore Medical Center The Bronx, New York
Montreal General Hospital Montreal, Quebec
NYP Brooklyn Methodist Brooklyn, New York
NYU Langone Medical Center, Bellevue Hospital New York, New York
Nelson Hospital Nelson,
New York Presbyterian/Queens Flushing, New York
North Shore University Hospital Manhasset, New York
Northern Westchester Hospital Mount Kisco, New York
Northwell Staten Island Hopsital Staten Island, New York
PENN Presbyterian Medical Cente Philadelphia, Pennsylvania
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE Recife,
QE II Health Sciences Center Halifax, Nova Scotia
Quebec Heart and Lung Institute Quebec,
Regina General Hospital Regina, Saskatchewan
Rhode Island Hospital Providence, Rhode Island
Robert Wood Johnson University Hospital New Brunswick, New Jersey Jeffrey L Carson, MD - (jeffrey.carson@rutgers.edu)
Rochester General Hospital Rochester, New York
Royal Alexandra Hospital Edmonton, Alberta
Royal Columbian Hospital New Westminster, British Columbia
Royal Perth Hospital Perth, Western Australia
Royal Victoria Hospital Montréal, Quebec
Rush University Medical Center Chicago, Illinois
Saint Luke's Mid America Heart Kansas City, Kansas
Santa Casa de Marília Cascata,
Sociedade Hospitalar Angelina Caron Centro,
Southside Hospital Bay Shore, New York
St. Boniface General Hospital Winnipeg, Manitoba
St. Joseph Mercy Health System Ypsilanti, Michigan
St. Joseph's Health Centre Hamilton, Ontario
St. Michael's Hospital Toronto, Ontario
Stony Brook Medicine Stony Brook, New York
Sunnybrook Health Sciences Centre Toronto, Ontario
Surrey Memorial Hospital Surrey, British Columbia
Taranaki Hospital New Plymouth,
The Memphis VAMC Memphis, Tennessee
The Miriam Hospital Providence, Rhode Island
The University of North Carolina at Chapel Hill Chapel Hill, North Carolina
Thomas Jefferson University Philadelphia, Pennsylvania
Tulane University School of Medicine New Orleans, Louisiana
University Hospital - LHSC London, Ontario
University of Alberta Hospital Edmonton, Alberta
University of Arkansas Medical Sciences (UAMS) Hospital Little Rock, Arkansas
University of Chicago Medical Center Chicago, Illinois Mary Harris-Moreno
University of Louisville Louisville, Kentucky
University of Michigan Ann Arbor, Michigan
University of Minnesota Medical Center Fairview Minneapolis, Minnesota
University of New Mexico Albuquerque, New Mexico
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
University of Toledo Medical Center Toledo, Ohio
University of Vermont Medical Center Burlington, Vermont
VAGLAHS Los Angeles, California
Vancouver General Hospital Vancouver, British Columbia
Victoria Heart Institute Victoria, Ontario
Victoria Hospital - LHSC London, Ontario
Virginia Commonwealth University Richmond, Virginia
WakeMed Health and Hospital Raleigh, North Carolina
Washington University St Louis, Missouri
Westchester Medical Center Valhalla, New York
Whangarei Hospital Whangarei,

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

Lisa Erickson, MPH - 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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Study Locations

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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 September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com)
Beth Israel Deaconess Boston, Connecticut
Cardinal Glennon Children's Medical Center St Louis, Missouri Deepika Bhatla, MD - (dbhatla@slu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Ann Haight, MD - (Ann.haight@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 Mark Walters, MD - (mwalters@mail.cho.org)
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 Lolie Yu, MD - (lyu@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 Nancy Bunin, MD - (buninn@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
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 Craig Sauter, MD - (sauterc@ccf.org)
Cohen Children's Medical Center of New York New Hyde Park, 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)
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 Jackson, Michigan Nalini Janakiraman, MD - (njanaki1@hfhs.org)
Indiana Blood & Marrow Transplantation Beech Grove, Indiana Luke Akard, MD - (lakard@ibmtindy.com)
Indiana University/Riley Hospital for Children Indianapolis, Indiana Jodi Skiles, MD - (jskiles@iu.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 Stiff, MD - (pstiff@lumc.edu)
M.D. Anderson Cancer Center Houston, Texas Elizabeth Shpall, MD - (eshpall@mdanderson.org)
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida Vivek Roy, MD - (roy.vivek@mayo.edu)
Mayo Clinic Arizona (adults) Phoenix, Arizona James Slack, MD - (slack.james@mayo.edu)
Mayo Clinic Rochester Rochester, Minnesota
Medical City Dallas Dallas, Texas Vikas Bhushan, MD - (vikas.bhushan@usoncology.com)
Medical College of Georgia Augusta, Georgia Claude Sportes, MD - (csportes@gru.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Hamadani Mehdi, MD - (mhamadani@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Michelle Hudspeth, MD - (hudspeth@musc.edu)
Memorial Sloan-Kettering Cancer Center New York, New York Ioannis Politikos, MBBS - (politiki@mskcc.org)
Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com)
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 Miami Beach, Florida 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 Michael Joyce, MD - (mjoyce@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 A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.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 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
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 Todd Roberts, MD - (todd.roberts@chartercare.org)
Roswell Park Cancer Institute Buffalo, New York Philip McCarthy, MD - (philip.mccarthy@roswellpark.org)
Rush University Medical Center Chicago, Illinois
Sarah Cannon BMT Program Nashville, Tennessee
Scripps Green Hospital La Jolla, California Jeffrey W Andrey, MD - (andrey.jeffrey@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 Sagun Goyal, MD - (sgoyal3@slu.edu)
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 Michael Carroll, MD - (carrolmp@sutterhealth.org)
Texas Children's Hospital - Baylor Medical Center Houston, Texas Robert Krance, MD - (rakrance@txch.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 Hana Safa, MD - (hsafah@tulane.edu)
UCLA Santa Monica, California Gary Schiller, MD - (gschiller@mednet.ucla.edu)
UCSF (adults) San Francisco, California
UCSF (peds) San Francisco, California
Univeristy of Mississippi Medical Center Jackson, Mississippi Carolyn Bigelow, MD - (cbigelow@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 San Diego, California Edward Ball, MD - (tball@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 William Tse, MD - (w0tse002@louisville.edu)
University of Massachusetts Worcester, Massachusetts Jan Cerny, MD - (Jan.Cerny@umassmemorial.org)
University of Miami (adult) Miami, Florida
University of Miami (peds) Miami, Florida
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
University of Oklahoma Health Science Center Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
University of Pennsylvania/Thomas Jefferson Pittsburg, 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 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)
Western Penn Hospital Pittsburg, Pennsylvania John Lister, MD - (Jlister@wpahs.org)
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 Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil)

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 * 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: * Testicular leukemia * CNS leukemia (CNS3) * Steroid pretreatment. * 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. 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. * 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 (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group). * 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, 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, 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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Study Locations

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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
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
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
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Children's Hospital London, Ontario
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Christchurch Hospital Christchurch,
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City of Hope Comprehensive Cancer Center Duarte, California
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
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Corewell Health Children's Royal Oak, Michigan
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Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
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Dayton Children's Hospital Dayton, Ohio
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Eastern Maine Medical Center Bangor, Maine
Edwards Comprehensive Cancer Center Huntington, West Virginia
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Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
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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
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington
Maimonides Medical Center Brooklyn, New York
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Marshfield Medical Center-Marshfield Marshfield, Wisconsin
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
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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
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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)
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
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)
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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)
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 - (research@sncrf.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)
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 Midwest Affiliate Peoria, Illinois
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
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)
UMC Cancer Center / UMC Health System Lubbock, Texas
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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
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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 Site Public Contact - (cancer-center@ufl.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)
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University of Rochester Rochester, New York
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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
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Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
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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
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)

Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation

Jewell, Andrea - Andrea.Jewell@vcuhealth.org

Rohan, Jennifer
NCT04409301
HM20019000
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, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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Virginia Commonwealth University Richmond, Virginia Jewell, Andrea - (Andrea.Jewell@vcuhealth.org)

Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

Cady P Noda, Pharm.D. - cady.noda@vcuhealth.org

Noda, Cady, Ploessl
NCT03964259
HM20016430
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Inclusion Criteria:

• Diagnosis of lymphoma or acute lymphoblastic leukemia
• Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
• Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
• Patients of childbearing potential must have a negative pregnancy test (serum or urine)
• Lactating female patients must agree not to nurse a child while on this trial
• All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:

• Trisomy 21
• History of dialysis within 30 days prior to study registration or currently on dialysis
• Polyuric renal dysfunction
• Pregnancy
• Known or suspected pleural effusion
• 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: Intravenous fluids
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
High Dose Methotrexate, HDMTX, Intravenous Fluids
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Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Richmond, Virginia Lindsey B Gwaltney, RN - (lbgwaltney@vcu.edu) Cady P Noda, Pharm.D. - (cady.noda@vcuhealth.org)

National Cancer Institute "Cancer Moonshot Biobank" (moonshot)

Castellanos, Natasha, Guzy - castellanosn@vcu.edu

Poklepovic, Andrew, S
NCT04314401
HM20020956
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Inclusion Criteria:
* Is consistent with OR has been diagnosed with one of the following: * Colorectal cancer: stage IV * Non-small cell or small cell lung cancer: stage III/IV * Prostate cancer: metastatic prostate cancer * Gastric cancer, not otherwise specified (NOS): stage IV * Esophageal cancer, NOS: stage IV * Adenocarcinoma of gastroesophageal junction: stage IV * High grade serous ovarian cancer: stage III/IV * Invasive breast carcinoma: stage III/IV * Melanoma: stage III/IV * Acute myeloid leukemia * Multiple myeloma * For the purposes of this study, * Re-staging is allowed * Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above * Patient should fit in one of the following four clinical scenarios (a-d) * Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR * Scheduled to begin treatment with a new regimen of standard of care therapy OR * Currently progressing on a regimen of standard of care therapy OR * Currently being treated with a regimen standard of care therapy, without evidence of progression * Requirements for fresh tissue biospecimen collections at enrollment: * For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment * For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy * For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure * For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR * The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling * Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state * Requirements for archival tissue: * For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE * For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED * Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that: * Contains the cancer type for which the participant is enrolled, and * Was collected no more than 5 years prior to initiation of therapy, and * Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and * Contains at least 10% tumor content. 70% tumor content is optimal, and * No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy * Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment * Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection * Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment * Age 13 or older * Any sex * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i) * NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status * NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status * NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either * Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+) * African American with triple negative (ER-PR-HER2-) * NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Exclusion Criteria:
* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial * For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed * Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy * Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion * Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use * Factor X inhibitors are permitted * Use of anti-platelet drugs are permitted * Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP) * NCI PDMR EXCLUSION CRITERIA: Patients with complete response * NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections * NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution
PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, OTHER: Medical Chart Review, PROCEDURE: Paracentesis, PROCEDURE: Positron Emission Tomography
Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Carcinoma, Fallopian Tube Carcinoma, Gastric Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Invasive Breast Carcinoma, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Melanoma, Metastatic Prostate Carcinoma, Multiple Myeloma, Ovarian Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinoma, Stage III Fallopian Tube Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Triple-negative Breast Carcinoma
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AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Audie L Murphy VA Hospital San Antonio, Texas
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Bayhealth Hospital Kent Campus Dover, Delaware Site Public Contact - (clinical_trials@bayhealth.org)
Bayhealth Hospital Sussex Campus Milford, Delaware Site Public Contact - (clinical_trials@bayhealth.org)
Blank Children's Hospital Des Moines, Iowa
Boca Raton Regional Hospital Boca Raton, Florida
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
Broward Health North Deerfield Beach, Florida
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Carle Cancer Center Urbana, 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)
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
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East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado Site Public Contact - (peaksresearch@imail.org)
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Harold Alfond Center for Cancer Care Augusta, Maine
Hartford Hospital Hartford, Connecticut
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Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
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Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Intermountain Health Platte Valley Hospital Brighton, Colorado Site Public Contact - (peaksresearch@imail.org)
Iowa Methodist Medical Center Des Moines, Iowa
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia Site Public Contact - (underberga@sjchs.org)
Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado Site Public Contact - (peaksresearch@imail.org)
MMP Surgical Care Casco Bay Portland, Maine Site Public Contact - (ClinicalResearch@mmc.org)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Maine Medical Partners Neurology Scarborough, Maine Site Public Contact - (ClinicalResearch@mmc.org)
Maine Medical Partners Surgical Care Portland, Maine
MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Cancer Care and IV Therapy - Sanford Sanford, 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 Franklin Hospital Farmington, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
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MaineHealth Maine Medical Center - Biddeford Biddeford, Maine
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MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Stephens Hospital Norway, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Urology - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Waldo Hospital Belfast, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina Site Public Contact - (research@ecuhealth.org)
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Hospital Fort Smith Fort Smith, Arkansas
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Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
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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
Mid Coast Hospital Brunswick, Maine Site Public Contact - (ctsucontact@westat.com)
Missouri Baptist Medical Center St Louis, Missouri
Mobile Infirmary Medical Center Mobile, Alabama
Monongalia Hospital Morgantown, West Virginia
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
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Montefiore Medical Center-Weiler Hospital 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)
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
Newton Medical Center Newton, New Jersey
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
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Novant Health Presbyterian Medical Center Charlotte, North Carolina
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
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Overlook Hospital Summit, New Jersey
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Penobscot Bay Medical Center Rockport, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Physicians' Clinic of Iowa PC Cedar Rapids, Iowa
Prisma Health Baptist Hospital Columbia, South Carolina
Prisma Health Greenville Memorial Hospital Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Roger Williams Medical Center Providence, Rhode Island Site Public Contact - (fdallesandro@chartercare.org)
SMC Center for Hematology Oncology Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
SSM Health Good Samaritan Mount Vernon, Illinois Site Public Contact - (gayla.hall@ssmhealth.com)
Saint James Community Hospital and Cancer Treatment Center Butte, Montana
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Saint Mary's Regional Medical Center Reno, Nevada
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San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
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Swedish Covenant Hospital Chicago, Illinois
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Thomas Hospital Fairhope, Alabama
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Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa Site Public Contact - (katherine-daprile@uiowa.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
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Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Veterans Affairs Loma Linda Healthcare System Loma Linda, California

STRIDE Biorepository

Lakshmanan Krishnamurti, MD - lakshmanan.krishnamurti@emory.edu

NCT02843347
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Inclusion Criteria:

• Age at least 15 years old to less than 41 years old
• Severe sickle cell disease [any clinically significant sickle genotype, for example, Hemoglobin SS (Hb SS), Hemoglobin SC (Hb SC) or Hemoglobin SBeta thalassemia (Hb S?), or Hemoglobin S-OArab genotype] with at least 1 of the following manifestations:
• Clinically significant neurologic event (stroke) or any neurological deficit lasting > 24 hours;
• History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy);
• An average of three or more pain crises per year in the 2-year period preceding enrollment or referral (required intravenous pain management in the outpatient or inpatient hospital setting);
• Administration of regular red blood cell (RBC) transfusion therapy, defined as receiving 8 or more transfusions per year(in the 12 months before enrollment to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome);
• An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ?
• 7 m/sec;
• Ongoing high impact chronic pain on a majority of days per month for at least 6 months.
• Adequate physical function as measured by all of the following:
• Karnofsky/Lansky performance score > or equal to 60
• Cardiac function: Left ventricular ejection fraction (LVEF) > 40%; or LV shortening fraction > 26% by cardiac echocardiogram or by Multi Gated Acquisition (MUGA) Scan
• Pulmonary function: Pulse oximetry with a baseline O2 saturation of ? 85% and diffusing capacity of the lung for carbon monoxide (DLCO) > 40% (corrected for hemoglobin)
• Renal function: Serum creatinine ? 1.5 x the upper limit of normal for age as per local laboratory and creatinine clearance >70 mL/min; or GFR > 70 mL/min/1.73 m2 by radionuclide Glomerular Filtration Rate (GFR)
• Hepatic function: Serum conjugated (direct) bilirubin < 2x upper limit of normal for age as per local laboratory; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 times upper limit of normal as per local laboratory.
Exclusion Criteria:

• Human Leukocyte Antigen (HLA) typing prior to referral (consultation with hematopoietic cell transplantation (HCT) physician). However, if a subject has had HLA typing with accompanying documentation that relatives were not HLA typed and that a search of the unrelated donor registry was not performed the subject will be considered eligible. Documentation will be reviewed and adjudicated by the Protocol Officer or his/her designee.
• Uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment.
• Seropositivity for HIV
• Previous HCT or solid organ transplant
• Participation in a clinical trial in which the patient received an investigational drug or device must be discontinued at enrollment.
• A history of substance abuse as defined by version IV of the Diagnostic & Statistical Manual of Mental Disorders (DSM IV).
• Demonstrated lack of compliance with prior medical care (determined by referring physician).
• Pregnant or breast feeding females.
• Inability to receive HCT due to alloimmunization, defined as the inability to receive packed red blood cell (pRBC) transfusion therapy. Additional Eligibility Criteria for Transplant after Biologic Assignment to the Donor Arm: Participants assigned to the Donor Arm at the time of biologic assignment are subject to additional transplant eligibility criteria as specified below. Additional, repeat clinical assessments prior to transplant should be obtained in accordance with institutional policies and standards of care in the interest of good clinical practice.
• Participants must have liver magnetic resonance imaging (MRI) (at least 90 days prior to initiation of transplant conditioning) to document hepatic iron content is required for participants who are currently receiving ?8 packed red blood cell transfusions for ?1 year or have received ?20 packed red blood cell transfusions (cumulative). Participants who have hepatic iron content ?7 mg Fe/g liver dry weight by liver MRI must have a liver biopsy and histological examination/documentation of the absence of cirrhosis, bridging fibrosis, and active hepatitis (at least 90 days prior to initiation of transplant conditioning).
• Cerebral MRI/magnetic resonance angiogram (MRA) within 30 days prior to initiation of transplant conditioning. If there is clinical or radiologic evidence of a recent neurologic event (such as stroke or transient ischemic attack) subjects will be deferred for at least 6 months with repeat cerebral MRI/MRA to ensure stabilization of the neurologic event prior to proceeding to transplantation.
• Documentation of participant's willingness to use approved contraception method until discontinuation of all immunosuppressive medications. This is to be documented in the medical record corresponding with the consent conference.
• Have a suitably matched HLA donor
• Willing and able to donate bone marrow
• Absence of anti-donor HLA antibodies
Procedure: Blood draw
Anemia, Sickle Cell
Biorepository, Genetics
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Study Locations

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Location Contacts
Augusta University Medical Center Augusta, Georgia Jeremy Pantin - (JPANTIN@gru.edu)
Barbara Ann Karmanos Cancer Institute Detroit, Michigan Paul Swerdlow - (swerdlow@karmanos.org)
Baylor College of Medicine/The Methodist Hospital Houston, Texas Premal Lulla - (lulla@bcm.edu)
Benioff Children's Hospital at Oakland Oakland, California Mark Walters - (MWalters@mail.cho.org)
Boston University Boston, Massachusetts Elizabeth Klings - (klingon@bu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Lakshmanan Krishnamurti, MD - (lakshmanan.krishnamurti@emory.edu)
Children's Hospital of New Orleans New Orleans, Louisiana Lolie Yu - (lyu@lsuhsc.edu)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Tim Olsen - (olsont@email.chop.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Beth Carella - (beth.carella@chp.edu)
Children's National Medical Center Washington D.C., District of Columbia Allistair Abraham - (AAbraham@childrensnational.org)
Cohen Children's Medical Center New Hyde Park, New York Indira Sahdev - (ISahdev@northwell.edu)
Dana Farber Cancer Institute/Brigham and Women's Hospital Boston, Massachusetts Zachariah Defilipp - (zdefilipp@mgh.harvard.edu)
Dana Farber Cancer Institute/Massachusetts General Hospital Boston, Massachusetts Joseph Antin - (jantin@partners.org)
Duke University Medical Center Durham, North Carolina Keith Sullivan - (keith.sullivan@duke.edu)
Emory Children's Center Atlanta, Georgia
Emory University Atlanta, Georgia Edmund Waller - (ewaller@emory.edu)
Foundation for Sickle Cell Research/Florida Sickle Inc. Hollywood, Florida Gershwin Blyden - (GBlyden@fscdr.org)
Grady Hospital Delaware, Ohio Fuad El Rassi - (fuad.elrassi@emory.edu)
Hackensack University Medical Center Hackensack, New Jersey Jennifer Krajewski - (JKrajewski@HackensackUMC.org)
Icahn School of Medicine at Mount Sinai New York, New York John Levine
Medical University of South Carolina Charleston, South Carolina Jennifer Jaroscak - (jaroscak@musc.edu)
Montefiore Medical Center/Albert Einstein School of Medicine Bronx, New York Murali Janakiram - (mjanakir06@gmail.com)
New York Presbyterian Brooklyn Methodist Hospital Brooklyn, New York Ayanna Baptiste - (amb9075@nyp.org)
Newark Beth Israel Medical Center Newark, New Jersey Alice J Cohen - (acohen@barnabashealth.org)
Ohio State University Columbus, Ohio Steven Devine - (steven.devine@osumc.edu)
Oregon Health Sciences University Portland, Oregon Trisha Wong - (wong@ohsu.edu)
Oschner Medical Center New Orleans, Louisiana Andrew Dalovisio - (andrew.dalovisio@ochsner.org)
University of Chicago Chicago, Illinois John Cunningham - (jcunning@peds.bsd.uchicago.edu)
University of Florida Gainsville Gainesville, Florida Paul Castillo - (castillopa@ufl.edu)
University of Iowa Iowa City, Iowa Arunkumar Modi - (Arunkumar-modi@uiowa.edu)
University of Miami Miami, Florida Lazaros Lekakis - (LLekakis@med.miami.edu)
University of Michigan Medical Center Ann Arbor, Michigan Greg Yanik - (gyanik@med.umich.edu)
University of North Carolina Hospital at Chapel Hill Chapel Hill, North Carolina Kimberly Kasow - (kimberly_kasow@med.unc.edu)
University of Oklahoma Oklahoma City, Oklahoma George Selby - (George-Selby@ouhsc.edu)
University of Texas Health Sciences Center Houston, Texas Harinder Juneja - (harinder.s.juneja@uth.tmc.edu)
University of Texas/MD Anderson CRC Houston, Texas Uday Popat - (upopat@mdanderson.org)
University of Virginia Charlottesville, Virginia Tamila Kindwall-Keller - (TLK5DE@hscmail.mcc.virginia.edu)
Virginia Commonwealth University Richmond, Virginia Christina Wiedl - (cwiedl@vcu.edu)
Washington University/St. Louis Children's Hospital St Louis, Missouri Mark Schroeder - (markschroeder@wustl.edu)
Weill Cornell Medical College New York, New York Tsiporah Shore - (Tbs2001@med.cornell.edu)

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 * Patients must be 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 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 * 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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Study Locations

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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
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
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 - (rryan@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 - (HemonCCTrials@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)
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
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
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
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
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 - (research@sncrf.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 Jude Midwest Affiliate Peoria, Illinois
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)
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 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 Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.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 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
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)

Crystalloids Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

Mason, Jessica - jessica.mason1@vcuhealth.org

de Wit, Marjolein
NCT03434028
HM20013528
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Inclusion Criteria:

• Age ? 18 years
• A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
• Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).
Exclusion Criteria:

• More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
• Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
• Unable to obtain informed consent
• Known pregnancy
• Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
• Blood pressure is at known or reported baseline level
• Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
• Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
• Treating physician unwilling to give additional fluids as directed by the liberal protocol
• Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
• Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
• Immediate surgical intervention planned such that study procedures could not be followed
• Prior enrollment in this study
Drug: Early Vasopressors, Drug: Early Fluids, drug: Ringer's (hartmann's) lactate solution, drug: Plasmalyte (crystalloid) solution, drug: Normal (0.9%, isotonic) saline solution, drug: Norepinephrine
Septic Shock, Symptoms, Signs, and lll-Defined Conditions (780-799)
Fluid management, Sepsis-induced hypotension, vasopressors
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Study Locations

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Location Contacts
Baystate Medical Center Springfield, Massachusetts
Beth Israel Medical Center New York, New York
Brigham and Women's Hospital Boston, Massachusetts
Brigham and Women's Hospital Boston, Massachusetts
Cleveland Clinic Foundation Cleveland, Ohio
Denver Health Medical Center Denver, Colorado
Duke University Medical Center Durham, North Carolina
Harborview Medical Center Seattle, Washington
Hennepin County Medical Center Minneapolis, Minnesota
Indiana University Health Methodist Hospital Indianapolis, Indiana
Intermountain Medical Center Murray, Utah
LDS Hospital Salt Lake City, Utah
Maine Medical Center Scarborough, Maine
Massachusetts General Hospital Boston, Massachusetts
McKay-Dee Hospital Ogden, Utah
Medical University of South Carolina Charleston, South Carolina
Montefiore Medical Center The Bronx, New York
Mt. Sinai Hospital Chicago, Illinois
Ohio State University Wexner Medical Center Columbus, Ohio
Oregon Health and Science University OHSU Portland, Oregon
Penn State Hershey Medical Center Hershey, Pennsylvania
Ronald Reagan UCLA Los Angeles, California
St. Joseph Hospital Bethpage, New York
St. Vincent Hospital Green Bay, Wisconsin
Stanford University Hospital Stanford, California
Swedish Hospital First Hill Seattle, Washington
Temple University Hospital Philadelphia, Pennsylvania
UCSF Fresno Fresno, California
UCSF San Francisco San Francisco, California
UPMC Mercy Pittsburgh, Pennsylvania
UPMC Presbyterian Pittsburgh, Pennsylvania
UPMC Shadyside Pittsburgh, Pennsylvania
University Medical Center (LSU) New Orleans, Louisiana
University Of Texas Health Science Center San Antonio, Texas
University Virginia Medical Center Charlottesville, Virginia
University of Arizona Tucson, Arizona
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Hospital Aurora, Colorado
University of Kentucky Lexington, Kentucky
University of Michigan Medical Center Ann Arbor, Michigan
University of Minnesota Medical Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Utah Health Sciences Center Salt Lake City, Utah
University of Washington Medical Center Seattle, Washington
Utah Valley Regional Medical Center Provo, Utah
VCU Medical Center Richmond, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia Mason, Jessica - (jessica.mason1@vcuhealth.org)
Wake Forest Baptist Health Winston-Salem, North Carolina
Yale New Haven Hospital New Haven, Connecticut

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery (ASTER)

Katie Oldmixon, RN - coldmixon@mgh.harvard.edu

Fowler, Alpha, A
NCT04291508
HM20023257
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Inclusion Criteria:

• Age ≥ 18 years
• Sepsis defined as:
• Clinical evidence of a known or suspected infection and orders written to administer antibiotics AND
• Hypotension as defined by the need for any vasopressor (and 1 liter of fluid already administered intravenously for resuscitation) OR respiratory failure defined by mechanical ventilation, BIPAP or CPAP at any level, or greater than or equal to 6 liters/minute of supplemental oxygen (criterion b must be met at time of enrollment)
• Admitted to a study site ICU (or intent for the patient to be admitted to a study site ICU) within 36 hours of presentation to the ED or admitted to the study site ICU within 36 hours of presentation to any acute care hospital
Exclusion Criteria:

• No consent/inability to obtain consent from the participant or a legally authorized representative
• Patient unable to be randomized within 36 hours of presentation to the ED or within 36 hours of presentation to any acute care hospital
• Diagnosis of cirrhosis by medical chart review
• Liver transplant recipient
• AST or ALT greater than five times upper limit of normal
• Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
• Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
• Hypersensitivity to Acetaminophen or Vitamin C
• Patient, surrogate or physician not committed to full support (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
• Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
• Chronic dialysis
• Current active kidney stone (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
• Multiple (>1) episodes of prior kidney stones, known history of oxalate kidney stones, or history of oxalate nephropathy. (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
• Kidney transplant recipient (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
• Use of home oxygen >3L/minute via nasal cannula for chronic cardiopulmonary disease
• Moribund patient not expected to survive 24 hours
• Underlying malignancy or other condition with estimated life expectancy of less than 1 month
• Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
• Prisoner
• Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C
• Treating team unwilling to use plasma (as opposed to point of care testing) for glucose monitoring (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial).
Drug: Intravenous Acetaminophen (room temperature), Drug: Intravenous Vitamin C (refrigerated), Drug: 5% Dextrose (room temperature), Drug: 5% Dextrose refrigerated
Acute Respiratory Distress Syndrome, Critical Illness, Respiratory Failure, Sepsis
ARDS, Acetaminophen, Vitamin C, Sepsis
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Study Locations

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Location Contacts
Baystate Medical Center Springfield, Massachusetts
Beth Israel Deaconess Medical Center Boston, Massachusetts
Carolinas Medical Center Charlotte, North Carolina
Cedars-Sinai Medical Center Los Angeles, California
Cleveland Clinic Foundation Cleveland, Ohio
Denver Health Medical Center Denver, Colorado
Fairview Southdale Hospital Edina, Minnesota
Harborview Medical Center Seattle, Washington
Hennepin County Medical Center Minneapolis, Minnesota
Henry Ford Medical Center Sterling Heights, Michigan
Intermountain Medical Center Murray, Utah
Maine Medical Center Scarborough, Maine
Massachusetts General Hospital Boston, Massachusetts
Medical University of South Carolina Charleston, South Carolina
Montefiore Medical Center-Moses Bronx, New York
Montefiore Medical Center-Weiler Bronx, New York
Mt. Sinai Hospital Chicago, Illinois
Ohio State University Wexner Medical Center Columbus, Ohio
Oregon Health and Science University Portland, Oregon
Ronald Reagan UCLA Medical Center Los Angeles, California
Sentara/EVMS Norfolk, Virginia
Stanford University Palo Alto, California
Swedish Hospital First Hill Seattle, Washington
Temple University Hospital Philadelphia, Pennsylvania
UC Davis Medical Center Sacramento, California
UCSF Fresno Fresno, California
UCSF Medical Center San Francisco, California
UPMC Presbyterian/Mercy/Shadyside/Magee Pittsburgh, Pennsylvania
University Medical Center New Orleans, Louisiana
University Of Texas Health Science Center San Antonio, Texas
University of Alabama Medical center Birmingham, Alabama
University of Arizona Tucson, Arizona
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Hospital Aurora, Colorado
University of Kentucky Lexington, Kentucky
University of Michigan Medical Center Ann Arbor, Michigan
University of Mississippi Medical Center Jackson, Mississippi
University of Utah Hospital Salt Lake City, Utah
University of Virginia Health System Charlottesville, Virginia
VCU Medical Center Richmond, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Wake Forest Baptist Medical Center Winston-Salem, North Carolina

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 Rhinelander, Wisconsin 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)

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 181 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 - (rryan@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 - (HemonCCTrials@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)
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 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
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
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
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
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)
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 - (research@sncrf.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 Jude Midwest Affiliate Peoria, Illinois
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)
UMC Cancer Center / UMC Health System Lubbock, Texas
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 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 Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.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
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML

Shattuck Clinical Trials - clinicaltrials@shattucklabs.com

NCT05275439
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Inclusion Criteria:

• Subject has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonisation/Good Clinical Practice (ICH/GCP) guidelines and applicable local regulations.
• Age ≥ 18 years.
• For subjects with AML, confirmation of AML diagnosis by 2016 World Health Organization (WHO) criteria [Arber, 2016] classification, excluding acute promyelocytic leukemia (APL).
• Subjects with MDS must have:
• morphologically confirmed diagnosis of MDS by 2016 WHO criteria [Arber, 2016] with <20% blasts in bone marrow per bone marrow biopsy/aspirate or peripheral blood.
• confirmation of intermediate, high or very high risk category by Revised International Prognostic Scoring System (IPSS-R)
• Subjects with AML must have relapsed/refractory disease (>5% blasts by manual aspirate differential, flow cytometry, or immunohistochemistry) following at least 1 prior line of therapy but no more than 4 prior lines of therapy.
• Subjects with relapsed/refractory disease (as defined in Inclusion criterion 5) following at least 1 prior line of therapy but no more than 4 prior lines of therapy for AML or MDS.
• Subjects diagnosed with MDS must be previously untreated. Prior MDS therapy with lenalidomide or supportive care in the form of transfusions or growth factors is allowed.
• All subjects must have documentation of at least one tumor protein 53 (TP53) gene mutation/deletion based on local test.
• Subjects with previously untreated de novo AML or secondary AML with TP53 gene mutation or deletion and who are unlikely to benefit from standard intensive induction therapy or refuse intensive induction therapy at time of enrollment are eligible. All subjects must have documentation of at least one TP53 gene mutation/deletion based on local test. Subjects with secondary AML after MDS must not have received prior chemotherapy or no more than 2 cycles of prior hypomethylating agent for MDS.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
• Laboratory values must meet the criteria outlined in the protocol.
• Willing to provide consent for bone marrow aspirate samples for exploratory research at baseline and on-treatment per schedule described in the Schedule of Assessments.
• For subjects with relapsed/refractory disease, recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of the first dose of study treatment.
• Male subjects with female partners of childbearing potential must have azoospermia from a prior vasectomy or underlying medical condition or agree to use an acceptable method of contraception during treatment and for 30 days (which exceeds 5 half-lives) or for the duration required by local regulatory guidance, whichever is longer, after last dose of study treatment.
Exclusion Criteria:

• Subject with relapsed or refractory disease has received treatment for AML or MDS with any of the following:
• Chimeric antigen receptor (CAR)-T cell therapy
• Prior treatment with anti-cluster of differentiation 47 (CD47) targeting agent or cluster of differentiation 40 (CD40) agonist within 28 days prior to
• the first dose of study treatment.
• Prior treatment with signal-regulatory protein alpha (SIRPα)-targeting antibody
• Other experimental therapies for AML or MDS within 14 days or at least 5 half- lives (whichever is shorter) prior to the first dose of study treatment
• Evidence of active central nervous system (CNS) involvement with leukemia
• Subjects requiring agents other than hydroxyurea to control blast counts within 14 days prior to the first dose of study treatment.
• Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial)
• [Only for Cohorts including Venetoclax in the regimen] Subject has received strong and/or moderate cytochrome P450, family 3, subfamily A (CYP3A) inducers within 7 days prior to the first dose of study treatment.
• Use of corticosteroids or other immunosuppressive medication, current or within 14 days of the first dose of study treatment
• Receipt of live attenuated vaccine within 30 days of first dose of SL-172154 treatment, the exception is that vaccines for coronavirus disease 19 (COVID-19) are permitted.
• Subject has active, uncontrolled infection (e.g, viral, bacterial, or fungal). Subjects are eligible if infection is controlled with antibiotics, antivirals and/or antifungals.
• [Only for Cohorts including Venetoclax in the regimen] Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
• Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of first dose of study treatment.
• Clinically significant or uncontrolled cardiac disease including any of the following:
• Myocarditis
• Unstable angina within 6 months from D1 of study treatment
• Acute myocardial infarction within 6 months from D1 of study treatment
• Uncontrolled hypertension
• New York Heart Association (NYHA) Class III or IV congestive heart failure
• Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, second- or third- degree atrioventricular (AV) block without a pacemaker, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia not stabilized on therapy)
• Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participation in the study.
• Subjects who have had any major surgical procedure within 14 days of first dose of study treatment.
• Subject is a woman who is pregnant or breast feeding or planning to become pregnant or breast feed while enrolled in this study.
• Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events (AEs) or compromised ability to provide written informed consent.
• Presence of another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with the monitoring of disease assessments in this study.
• Known hypersensitivity to any of the study medications including excipients of Azacitidine.
• Has undergone solid organ transplantation.
• Known or active human immunodeficiency virus (HIV) infection
• Known or active infection with hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if hepatitis C virus (HCV) antibody (Ab) test is positive check for HCV ribonucleic acid [RNA]).
Drug: SL-172154
Acute Myeloid Leukemia, Myelodysplastic Syndromes
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Baylor Scott & White Research Institute Dallas, Texas Meiyan Jiang, RN - (Meiyan.Jiang@BSWHealth.org) MD - (Jana.Reynolds@usoncology.com)
City of Hope Duarte, California Manjoyt Nanhwan, SC
Dana-Farber Cancer Institute Boston, Massachusetts Taylor Robertson - (TaylorA_Robertson@DFCI.HARVARD.EDU)
Gabrail Cancer Center Canton, Ohio
MD Anderson Cancer Center Houston, Texas Yamilet Saker, RN - (YSaker1@mdanderson.org)
Moffitt Cancer Center Tampa, Florida Chelsea Conner, CCRP - (chelsea.conner@moffitt.org)
Norton Cancer Institute Louisville, Kentucky Sandy M Stencavage, RN - (Sandy.Stencavage@nortonhealthcare.org) M
Princess Margaret Cancer Centre Toronto, Ontario Erik Adapon, RN - (Erik.Adapon@uhn.ca) - (Brenna.Mahony@uhn.ca)
Roswell Park Comprehensive Cancer Center Buffalo, New York Danielle Wittek, BA - (Danielle.Wittek@RoswellPark.org)
START Midwest Grand Rapids, Michigan Jade Blakeman, RN - (jade.blakeman@startmidwest.com)
UCLA Medical Center-Bowyer Oncology Center Los Angeles, California Bruck Habtemariam - (bhabtemariam@mednet.ucla.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania Amy Rodgers - (rodgersa@upmc.edu)
University of Cincinnati Medical Center Cincinnati, Ohio Emily Greve, MS - (greveei@ucmail.uc.edu)
University of Michigan Ann Arbor, Michigan Roxana Taralunga - (roxanat@med.umich.edu)
University of North Carolina, Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Kiya Birku - (kbirku@email.unc.edu)
VCU Massey Cancer Center Richmond, Virginia Caryn Weir, RN - (cweir@vcu.edu)
Yale Cancer Center New Haven, Connecticut Anne Caldwell, RN - (anne.caldwell@yale.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 and above (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 less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 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 less than \[\<\]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 Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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Asan Medical Center Seoul,
Baylor University Medical Center Dallas, Texas
CHRU Nancy 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,
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo São Paulo,
Gold Coast University Hospital Southport,
Gunmaken Saiseikai Maebashi Hospital Maebashi,
Gustave Roussy Villejuif,
Guys and St Thomas NHS Foundation Trust London,
Hadassah University Hospita Ein Kerem Jerusalem,
Henan Cancer Hospital Zhengzhou,
Hokkaido University Hospital Sapporo, Hokkaido
Hopital Jean Minjoz Besançon,
Hopital Maisonneuve Rosemont Montreal, Quebec
Hopital Saint Louis Paris,
Hopital trousseau- APHP Paris,
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,
Houston Methodist Hospital Houston, Texas
Institut Paoli Calmettes Marseille,
Institut Universitaire du Cancer Toulouse Oncopole Toulouse,
Institut de Cancerologie Strasbourg Europe ICANS Strasbourg,
Institute of Hematology and Blood Diseases Hospital Tianjin,
Instituto D Or de Pesquisa e Ensino Salvador,
Instituto D Or de Pesquisa e Ensino IDOR São Paulo,
Kanazawa University Hospital Kanazawa,
Karmanos Cancer Institute Detroit, Michigan
Kobe City Medical Center General Hospital KobeShi, Hyōgo
Kyushu University Hospital Fukuoka,
Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire
Liga Norte Riograndense Contra O Cancer Natal,
MD Anderson Houston, Texas
Maine Health Scarborough, Maine
Massachusetts General Hospital Boston, 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 Showa-Ku Nagoya,
Nanfang Hospital of Southern Medical Hospital Guangzhou,
National Cancer Center Hospital East Kashiwa,
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,
The Clatterbridge Cancer Centre Liverpool,
The First Affiliated Hospital of NanChang University Nanchang,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
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 California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Fukui Hospital Yoshida-gun, Fukui
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,
Zhongda Hospital Southeast University Nanjin,
the First Hospital of Jilin University Changchun,

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

ctrrecruit@vcu.edu

NCT05600894
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Inclusion Criteria:
* A diagnosis of an MDS/MPN "overlap" syndrome with \>= 5% marrow blasts (including monocytic blast equivalent in case of CMML). Hydroxyurea may be used to control counts up until the start of therapy * White blood cell (WBC) \< 25,000/mm\^3. Treatment with hydroxyurea is permitted to lower the WBC to reach this criterion * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with venetoclax in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert's syndrome) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN OR =\< 5.0 x institutional ULN for patients with liver metastases * Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * 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 * 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. Hormonal therapy for prior or concurrent malignancy is allowed * 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 * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible * Ability to swallow pills
Exclusion Criteria:
* Patients with need for emergent disease-directed therapy excluding hydroxyurea * More than one cycle of previous MDS/MPN-directed therapy, or MDS-directed therapy including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine, excluding hydroxyurea. Prior use of erythropoietin stimulating agents (ESA) and thrombopoietic agents is allowed, but must be discontinued 4 weeks prior to study treatment * Patients currently or previously receiving an investigational agent or device within 4 weeks of the first dose of treatment * Patients with symptomatic uncontrolled central nervous system (CNS) disease. Imaging to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days * Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment and are unwilling to discontinue consumption of these throughout the receipt of study drug * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or venetoclax * Patients with uncontrolled intercurrent illness (e.g. requiring intravenous therapy) at the discretion of the investigator * Pregnant women are excluded from this study because venetoclax and ASTX727 have 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 venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. These potential risks may also apply to other agents used in this study. Patients must be post-menopausal or with evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 * Post-menopausal is defined as: * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age * Radiation-induced oophorectomy with last menses \> 1 year ago * Chemotherapy-induced menopause with \> 1 year interval since last menses * Surgical sterilization (bilateral oophorectomy or hysterectomy) * Women of child-bearing potential must agree to use adequate contraception (hormonal birth control or abstinence) prior to study entry and for the duration of study participation, and for 6 months following completion of study treatment. 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. Men treated or enrolled on this protocol must also agree to use adequate contraception (latex or synthetic condom or abstinence) prior to the study, for the duration of study participation, and 3 months after completion of venetoclax and ASTX727 administration * Patients with any other medical condition for which the expected survival is below 12 months * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or assessment of the investigational regimen * Patients with uncontrolled infection at the time of study entry
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Venetoclax
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm
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Beth Israel Deaconess Medical Center Boston, Massachusetts
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Los Angeles General Medical Center Los Angeles, California
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
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)
NYP/Weill Cornell Medical Center New York, New York
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USC / Norris Comprehensive Cancer Center Los Angeles, California
University Health Network-Princess Margaret Hospital Toronto, Ontario Site Public Contact - (clinical.trials@uhn.on.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 Chicago Medicine-Orland Park Orland Park, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

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, age \> 75 years), organ dysfunction, or disease biology * Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification 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 and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible * Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors * Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP) * Patient must be assigned to this protocol by the myeloMATCH MSRP * 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 registration to rule out pregnancy. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or 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) * Patient of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an 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 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 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN * Either measured or estimated by Cockcroft-Gault equation * Creatinine clearance of ≥ 30 mL/min/1.73m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial * Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF). NOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02 * 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 2B or better * Patients must not have an active or 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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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
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)
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
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 Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
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)
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 - (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 Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
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Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma

ctrrecruit@vcu.edu

NCT05602194
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis * Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL) * Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used) * Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and * Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline * SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline * For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days * PEDIATRIC PATIENTS (AGE 15-17 years): * A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR * A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment): * 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2. * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped * 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard). * ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight * An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc * Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and * First dose of asparaginase must be planned within the first week of induction therapy, and * Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen) * Note: Co-enrollment on a therapeutic consortia trial is not required * 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:
* Down syndrome * Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other) * Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3) * Unable to tolerate oral formulation of study drug at enrollment * Patients who received chemotherapy or treatment for a prior malignancy are not eligible * The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented * Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. 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
PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic 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
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 Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
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 Site Public Contact - (connie.szczepanek@crcwm.org)
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
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 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 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 Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@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)
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)
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
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)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
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)
East Tennessee Childrens Hospital Knoxville, Tennessee
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
GenesisCare USA - Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Las Vegas Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
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)
Hospital for Sick Children Toronto, Ontario
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-San Diego Mission San Diego, California Site Public Contact - (clinical.trials@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
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Loma Linda University Medical Center Loma Linda, California
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
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)
Miami Cancer Institute Miami, Florida
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
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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
Solid Tumors, Hematologic Malignancies
PD1, PD-1, PDL1, PD-L1
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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 S.A. ( 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
Anhui Provincial Hospital-Cancer Chemotherapy Department ( 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 Hospital Cebeci ( Site 1306) Ankara,
Antoni van Leeuwenhoek Ziekenhuis ( Site 1551) Amsterdam, North Holland
Arizona Cancer Center at UMC North ( Site 0018) Tucson, Arizona
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
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,
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
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
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
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 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
CIMCA ( Site 3900) San José,
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1024) Fortaleza, Ceará
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,
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525) Rennes, Ille-et-Vilaine
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 Hopitalier Intercommunal Creteil ( Site 2514) Créteil, Val-de-Marne
Centre Hospitalier Annecy Genevois ( Site 2554) Epagny Metz Tessy, Haute-Savoie
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 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 Investigaciones ( Site 2755) Viña del Mar, Región de Valparaíso
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-Ambulatorium Chemioterapii ( 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 District,
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) Bangkok, 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 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
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) Izmir,
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
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) Bangkok, 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, Olomoucký kraj
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
Fox Chase Cancer Center ( Site 0042) Philadelphia, Pennsylvania
Fred Hutchinson Cancer Center ( Site 0024) Seattle, 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 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
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,
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
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 Nossa Senhora da Conceição ( Site 1011) Porto Alegre, Rio Grande do Sul
Hospital Privado Universitario de Córdoba ( Site 1354) Córdoba,
Hospital Provincial del Centenario ( Site 1359) Rosario, Santa Fe Province
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 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, Andalusia
Hospital Universitario de Donostia ( Site 0890) San Sebastian- Donostia, Basque Country
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.E.U. Medical Point Hastanesi-Oncology ( Site 1310) Izmir,
IDIM - Instituto de Investigaciones Metabólicas ( Site 1362) Ciudad de Buenos Aires, Buenos Aires
IMAT S.A.S ( Site 2703) Montería, Departamento de Córdoba
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 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 Cancerología-Oncology ( Site 2702) Medellín, Antioquia
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363) Mar del Plata, Buenos Aires
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
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) Napoli,
Istituto Oncologico Veneto IRCCS ( Site 1976) Padua, Veneto
Istituto di Candiolo - IRCCS ( Site 1960) Candiolo, Torino
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, Región de la Araucanía
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
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) Sayama, Osaka
Kindai University Hospital ( Site 3135) Sayama, Osaka
Kindai University Hospital ( Site 3166) Sayama, 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
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,
Liverpool Hospital-Medical Oncology ( Site 3021) Liverpool, New South Wales
London Regional Cancer Program - LHSC ( 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,
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 3657) Kryvyi Rih, Dnipropetrovsk Oblast
MNPE Regional Center of Oncology ( Site 3665) Kharkiv, Kharkivs’ka 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 Hospital ( Site 2811) Toronto, Ontario
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031) Miami Beach, Florida
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) Zaporizhzhia, Zaporizhzhia Oblast
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
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 Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1210) Saint Petersburg, Sankt-Peterburg
National Taiwan University Hospital ( Site 3200) Taipei,
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
ONCOCENTRO APYS-ACEREY ( Site 2758) Viña del Mar, Región de Valparaíso
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
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
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 International Cancer Institute ( Site 3129) Chuo-ku, Osaka
Osaka Medical and Pharmaceutical University Hospital ( Site 3167) Takatsuki, 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
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
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
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,
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, Kharkivs’ka 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
Samsung Medical Center ( Site 0950) Seoul,
Samsung Medical Center ( Site 0970) 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,
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
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) Bethlehem, Pennsylvania
St. Marianna University Hospital ( Site 3182) Kawasaki, Kanagawa
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
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna ( Site 1601) Poznan, Greater Poland 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,
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 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 Xi an Jiaotong University ( Site 3489) XiAn, Shanxi
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
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 - Westwood (Building 100) ( Site 0009) Los Angeles, California
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) San Francisco, California
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
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
Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1413) Budapest,
VCU Health Adult Outpatient Pavillion ( Site 0080) Richmond, Virginia
Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060) Nashville, Tennessee
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
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
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969) Siena,

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (ELEMENT-MDS)

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

NCT05949684
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Inclusion Criteria * Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:. i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood. * Participant is not transfusion dependent (NTD) based on IWG2018 criteria. * Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization. * Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L. * Participant has symptoms of anemia:. i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period. * Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required. Exclusion Criteria * Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases). * Participant with known history of diagnosis of AML. * Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization. * Participant with a history of pure red cell aplasia and/or antibody against erythropoietin. * Other protocol-defined Inclusion/Exclusion criteria apply.
BIOLOGICAL: Luspatercept, BIOLOGICAL: Epoetin Alfa
Myelodysplastic Syndromes
Luspatercept, BMS-986346, ACE-536, Myelodysplastic Syndrome, Epoetin alfa, Erythropoietin stimulating agent (ESA), Myelodysplastic Syndromes (MDS), Anaemia
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Show 169 locations

Study Locations

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Location Contacts
ASST Grande Ospedale Metropolitano Niguarda Milan,
Advanced Research Tamarac, Florida
All India Institute of Medical Sciences Bhubaneswar,
American Oncology Partners, PA Bethesda, Maryland
Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta
Attikon General University Hospital Chaïdári,
Austin Health Heidelberg, Victoria
Auxilio Mutuo Cancer Center San Juan,
Azienda Ospedaliera Ordine Mauriziano di Torino Torino,
Azienda Ospedaliera Universitaria Careggi Florence,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma Verona,
BRCR Global Plantation, Florida
Baptist MD Anderson Cancer Center Jacksonville, Florida
Beijing Peking Union Medical College Hospital Beijing, Beijing Municipality
Blacktown Hospital Blacktown, New South Wales
Blue Ridge Cancer Care Roanoke, Virginia
Bradfordhill Santiago,
CHU Bordeaux Haut-Leveque Pessac,
CHU Grenoble Alpes La Tronche,
Cancer and Blood Specialty Clinic Los Alamitos, California
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy,
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours, Indre-et-Loire
Centre Hospitalier Universitaire d'Angers Angers,
Centre Hospitalier Universitaire de Nice - Hopital L'archet Nice, Alpes-Maritimes
Centro Medico Barrio Parque Buenos Aires,
Centro de Investigacion Clinica de Oaxaca Oaxaca City,
Clínica Inmunocel Santiago, Santiago Metropolitan
Coffs Harbour Health Campus Coffs Harbour, New South Wales
Community Cancer Institute Clovis, California
Compassionate Cancer Care Medical Group Fountain Valley, California
D&H Cancer Research Center LLC Margate, Florida
Enroll SpA Santiago,
FALP Santiago,
Fakultni Nemocnice Ostrava Ostrava - Poruba,
Fakultní nemocnice Brno Bohunice Brno, Brno-město
Florida Cancer Specialists - North St. Petersburg, Florida
Florida Cancer Specialists - South Fort Myers, Florida
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, MI
Fondazione Policlinico Tor Vergata Rome, Lazio
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Rome, Lazio
Fundación Cardiovascular de Colombia Piedecuesta, Santander Department
Gemeinschaftspraxis Dres. med. Björn Schöttker & Dominik Pretscher Würzburg,
Gemeinschaftspraxis für Hämatologie und Onkologie Münster Münster, North Rhine-Westphalia
General Hospital of Athens "G. Gennimatas" Athens, Attikí
General Hospital of Athens "Laiko" Goudi, Athens,
Grande Ospedale Metropolitano - Presidio Morelli Reggio Calabria,
Gustave Roussy Villejuif,
Halifax Health Medical Center Daytona Beach, Florida
Hartford Hospital (HH) Hartford, Connecticut
Hattiesburg Clinic Hematology/Oncology Hattiesburg, Mississippi
Hemato Oncology Clinic Ahmedabad,
Hematológica Alta Especialidad SC, consultorio 830 Huixquilucan,
Hemorio Rio de Janeiro,
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet Eger,
Hopital Saint-Louis Paris,
Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires
Hospital Clinico de Valencia Valencia,
Hospital La Princesa Madrid,
Hospital Pablo Tobon Uribe Medellín, Antioquia
Hospital Sao Lucas da PUCRS Porto Alegre,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario Central de Asturias Oviedo, Principality of Asturias
Hospital Universitario Virgen Nieves Granada,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario Walter Cantidio Fortaleza,
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Salamanca,
Hospital das Clinicas FMUSP São Paulo,
Humanitas Rozzano, Milano
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
InVO Institut für Versorgungsforschung in der Onkologie Koblenz, Rhineland-Palatinate
Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat, Catalunya [Cataluña]
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse,
Institute of Medical Sciences and Sum Hospital Bhubaneswar, Odisha
Institute of hematology&blood disease hospital Tianjin, Tianjin Municipality
Instituto Alexander Fleming Capital Federal, Buenos Aires
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City, DIF
Jiangsu Province Hospital Nanjing, Jiangsu
John Muir Health - Behring Pavilion Walnut Creek, California
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey
Kadlec Clinic Hematology and Oncology Kennewick, Washington
Kliniken Ostalb, Stauferklinikum Mutlangen,
Local Institution - 0028 Salt Lake City, Utah
Local Institution - 0031 Detroit, Michigan
Local Institution - 0034 Chicago, Illinois
Local Institution - 0043 Changchun, Jilin
Local Institution - 0075 Chengdu, Sichuan
Local Institution - 0095 Cáceres,
Local Institution - 0096 Majadahonda, Madrid, Comunidad de
Local Institution - 0097 New Orleans, Louisiana
Local Institution - 0098 Porto,
Local Institution - 0109 Chile, Santiago Metropolitan
Local Institution - 0117 Montpellier,
Local Institution - 0118 Seoul,
Local Institution - 0119 Buenos Aires,
Local Institution - 0120 Sagamihara, Kanagawa
Local Institution - 0121 Shimotsuga, Tochigi
Local Institution - 0122 Osaka,
Local Institution - 0123 Huixquilucan,
Local Institution - 0124 Nagasaki,
Local Institution - 0125 Wangen I. Allgaeu, Baden-Wurttemberg
Local Institution - 0126 Mexico City, Mexico City
Local Institution - 0177 Bengaluru, Karnataka
Local Institution - 0185 Hyderabad,
Local Institution - 0186 New Delhi,
Local Institution - 0213 Seattle, Washington
Local Institution - 0220 Ocala, Florida
Local Institution - 0223 La Tronche, Isère
Local Institution - 0230 Tokushina-Shi, Tokushima
Local Institution - 0232 Pikeville, Kentucky
Local Institution - 0237 San Juan,
Local Institution - 0240 Honolulu, Hawaii
Local Institution - 0242 Pátrai, Achaḯa
Local Institution - 0250 Kempten (Allgäu), Bavaria
Local Institution - 0255 Lübeck,
Local Institution - 0273 Amagasaki, Hyōgo
Local Institution - 0281 Oulu, North Ostrobothnia
MTZ Clinical Research powered by Pratia Warsaw,
Metro-Minnesota Community Clinical Oncology Saint Louis Park, Minnesota
Moffitt Cancer Center Tampa, Florida
Monash Health Clayton, Victoria
Northwest Cancer Centers, P.C. Dyer, Indiana
Northwestern Memorial Hospital Chicago, Illinois
Oncomédica S.A.S Montería,
Onkologie Erding Erding, Bavaria
Orchard Healthcare Research Inc. Skokie, Illinois
Our Lady of the Lake RMC Baton Rouge, Louisiana
Peking University People's Hospital Beijing,
People's Hospital of Henan Province Zhengzhou, Henan
Pindara Private Hospital Benowa, Queensland
Pontchartrain Cancer Center Covington, Louisiana
Pratia Onkologia Katowice Katowice,
Praxis fur Hamatologie und Onkologie Berlin,
Rajiv Gandhi Cancer Institute And Research Centre Delhi,
Royal Prince Alfred Hospital Camperdown, New South Wales
Semmelweis Egyetem Budapest,
Shaanxi Provincial People's Hospital Xi’an, Shanxi
Shanghai Sixth People's Hospital Shanghai, Shanghai Municipality
Sociedad De Oncologia Y Hematologia Del Cesar Valledupar, Cesar Department
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu Wałbrzych, Silesian Voivodeship
St. Joseph Hospital Bethpage, New York
St. Paul's Hospital Vancouver, British Columbia
Sunnybrook Health Sciences Centre Toronto, Ontario
Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza, Szabolcs-Szatmár-Bereg
The Affiliated Hospital of Qingdao University Shandong,
The First Affiliated Hospital of NanChang University Nanchang,
The First Affiliated Hospital of Soochow University Suzhou,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang
The First Hospital of China Medical University Shenyang, Liaoning
The First Hospital of Harbin Harbin, Heilongjiang
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio
The Second Afilliated Hospital of Hebei Medical University Shijiazhuang, Hebei
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) Los Angeles, California
Unidad Médica Onco-Hematológica Puebla City,
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei
Universitaetsklinikum Duesseldorf Düsseldorf,
Universitatsklinikum Jena Jena,
Universitatsklinikum Leipzig Leipzig, Saxony
University General Hospital of Alexandroupoli Alexandroupoli, Anatolikí Makedonía Kai Thráki
University Hospital of Patras Pátrai,
University of Tennessee Medical Center Knoxville, Tennessee
University of Texas MD Anderson Cancer Center Houston, Texas
Uniwersyteckie Centrum Kliniczne Gdansk,
VCU Health Adult Outpatient Pavillion Richmond, Virginia
Ventura County Hematology Oncology Specialists Oxnard, California
Victoria Hospital & Children's Hospital - London Health Sciences Centre London, Ontario
Vseobecna Fakultni Nemocnice v Praze Prague,
Xiangya Hospital Central South University Changsha,
Yale-New Haven Hospital New Haven, Connecticut

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 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 requiring no more than chronic hormonal therapy, or localized breast cancer 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 patient 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 agree 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 - James Beck Cancer Center Rhinelander, Wisconsin
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin
Aspirus Regional Cancer Center Wausau, Wisconsin
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
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
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 McKee Medical Center Loveland, Colorado
Banner North Colorado Medical Center Greeley, 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-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-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 Site Public Contact - (connie.szczepanek@crcwm.org)
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
Commonwealth Cancer Center-Corbin Corbin, Kentucky
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana 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
Creighton University Medical Center Omaha, Nebraska
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
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)
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
Flaget Memorial Hospital Bardstown, Kentucky
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 - (HemonCCTrials@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 Site Public Contact - (Jeffh@columbusccop.org)
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
Henry Ford Health Providence Southfield Hospital Southfield, Michigan Site Public Contact - (kfife3@hfhs.org)
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
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)
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
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)
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
Langlade Hospital and Cancer Center Antigo, Wisconsin
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
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
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 - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
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 Chattanooga, Tennessee Site Public Contact - (Jeffh@columbusccop.org)
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 Durango, Colorado
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California
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MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

ctrrecruit@vcu.edu

NCT05564390
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Inclusion Criteria:
* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. * Participants must be \>= 18 years of age. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. * Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment. * Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy * Note: active hormonal therapy is allowed * Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration. * Participants must agree to have translational medicine specimens submitted. * Participants must be offered the opportunity to participate in specimen banking. * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP. * 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. * 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. * The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.
PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Busulfan, PROCEDURE: Chest Radiography, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography Test, DRUG: Enasidenib, DRUG: Fludarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, DRUG: Melphalan, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Olutasidenib, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography, RADIATION: Total-Body Irradiation, DRUG: Venetoclax
Acute Myeloid Leukemia, Myelodysplastic Syndrome
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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta Site Public Contact - (ctsucontact@westat.com)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
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)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec
CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec
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)
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)
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
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, 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)
Edward Hines Jr VA Hospital Hines, Illinois
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
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ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
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Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
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William S Middleton VA Medical Center Madison, Wisconsin
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A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Chris Korth - clinicaltrials@puretechhealth.com

NCT05829226
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Inclusion Criteria:
* Patients ≥ 18 years of age at the time of obtaining informed consent. * Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care. * Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available * Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies. * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Patient must meet the following criteria as indicated on the clinical laboratory tests: oWhite blood cell (WBC) count at the time of the first dose of \< 25,000/uL. oAspartate aminotransferase or alanine aminotransferase ≤ 3 × upper limit of normal (ULN; ≤ 5.0× ULN if considered to be due to leukemic involvement). oTotal bilirubin ≤ 2 × ULN (≤ 3 × ULN if considered to be due to leukemic involvement orGilbert's syndrome). oCreatinine clearance of ≥ 60 mL/min.
Exclusion Criteria:
* Patient diagnosed with acute promyelocytic leukemia (APL). * Patient has active malignant tumors other than AML/MDS * Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion. * Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD. * Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy * Patient has had major surgery within 4 weeks prior to the first study dose. * Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%. * Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation.
DRUG: LYT-200, DRUG: Venetoclax, DRUG: Azacitidine, DRUG: Decitabine
AML, Adult Recurrent, MDS
AML Recurrent, AML Relapsed, AML Refractory, Hematological Cancer, Gal-9, Immuno-oncology, MDS, MDS High Risk
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Study Locations

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Location Contacts
Baptist Health South Florida-Miami Cancer Institute Miami, Florida
Cedars-Sinai Medical Center Los Angeles, California
Karmanos Cancer Institute Detroit, Michigan
Mass. General Hospital-Harvard Boston, Massachusetts
Norton Healthcare-Norton Cancer Institute Louisville, Kentucky
Rhode Island Hospital Providence, Rhode Island
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
University of California Irvine Medical Center Orange, California
Virginia Commonwealth University Medical Center Richmond, Virginia

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (CaDAnCe-101)

BeOne Medicines - clinicaltrials@beonemed.com

NCT05006716
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Inclusion Criteria :
• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
• Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
• For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
• Measurable disease by radiographic assessment or serum IgM level (WM only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria:

• Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
• Requires ongoing systemic treatment for any other malignancy
• Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
• Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: BGB-16673
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
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Study Locations

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Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken
American Oncology Partners of Maryland Pa Bethesda, Maryland
Arensia Exploratory Medicine Llc Tbilisi,
Arthur Je Child Comprehensive Cancer Centre Calgary, Alberta
Asan Medical Center Seoul,
Augusta University Augusta, Georgia
Austin Health Heidelberg, Victoria
British Columbia Cancer Agency the Vancouver Centre Vancouver, British Columbia
CHU Henri Mondor Créteil,
Calvary Mater Newcastle Waratah, New South Wales
Cancer Institute Hospital of Jfcr Kotoku, Tokyo
Centre Henri Becquerel Rouen,
Centre Leon Berard Lyon,
Centre de Lutte Contre Le Cancer Institut Bergonie Bordeaux,
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Porto Alegre,
Centroricerche Cliniche Di Verona Srl Verona,
Chiba Cancer Center Chiba, Chiba
Chu Montpellier Hopital Saint Eloi Montpellier,
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) Québec,
Churchill Hospital Oxford University Hospital Nhs Trust Headington,
Columbia University Medical Center New York, New York
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Concord Repatriation General Hospital Concord, New South Wales
Cross Cancer Institute Edmonton, Alberta
Dana Farber Cancer Institute Boston, Massachusetts
Derriford Hospital Plymouth,
Dokuz Eylul University Balçova,
Edinburgh Cancer Centre Edinburgh,
Erciyes University Kayseri,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fred Hutchinson Cancer Research Center Seattle, Washington
Freeman Hospital Newcastle upon Tyne,
Honor Health Research Institute Scottsdale, Arizona
Hopital Claude Huriez Chu Lille Lille,
Hopital Estaing Clermontferrand,
Hopital de la Pitie Salpetriere Paris,
Hospital Alemão Oswaldo Cruz São Paulo,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Erasto Gaertner Curitiba,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Nove de Julho Dasa São Paulo,
Hospital Santa Rita de Cassia Afecc Vitória,
Hospital Sirio Libanes Brasilia Brasília,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda,
Hospital Universitario Vall Dhebron Barcelona,
Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi
Institut Paoli Calmettes Marseille,
Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo,
Istituto Europeo Di Oncologia Milan,
Karmanos Cancer Institute Detroit, Michigan
Karolinska Universitetssjukhuset Solna Stockholm,
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen München,
Klinikum Johannes Gutenberg Universitaet Mainz Mainz,
Linear Clinical Research Nedlands, Western Australia
MD Anderson Cancer Center Houston, Texas
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Mayo Clinic Jacksonville Jacksonville, Florida
Mayo Clinic Phoenix Phoenix, Arizona
Mayo Clinic Rochester Rochester, Minnesota
Md Anderson Cancer Center Madrid Spain Madrid,
Memorial Sloan Kettering Cancer Center MSKCC New York, New York
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida
Niguarda Cancer Center Division of Hematology Milan,
Norton Cancer Institute Pavilion Louisville, Kentucky
Nottingham University Hospitals NHS Trust Nottingham,
Ondokuz Mayis University Samsun,
Ospedale San Raffaele Milan,
Perth Blood Institute West Perth, Western Australia
Peter MacCallum Cancer Centre Melbourne,
Policlinico Sorsola Malpighi, Aou Di Bologna Bologna,
Princess Alexandra Hospital Woolloongabba, Queensland
Princess Margaret Cancer Centre Toronto, Ontario
Pusan National University Hospital Busan,
Real E Benemerita Associacao Portuguesa de Sao Paulo São Paulo,
Roswell Park Comprehensive Cancer Center Buffalo, New York
Sahlgrenska University Hospital Hematology Gothenburg,
Sakarya Training and Research Hospital Sakarya,
Samsung Medical Center Seoul,
Seoul National University Hospital Seoul,
Severance Hospital Yonsei University Health System Seoul,
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo,
Southeastern Regional Medical Center Newnan, Georgia
St Jamess University Hospital Leeds,
St Vincents Hospital Melbourne Fitzroy, Victoria
Stanford Medicine Palo Alto, California
Tampa General Hospital Cancer Institute Tampa, Florida
Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee
Tennessee Oncology, Pllc Nashville Nashville, Tennessee
The Alfred Hospital Melbourne, Victoria
The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi
The Institute of Oncology, Arensia Exploratory Medicine Chisinau,
UCLA Santa Monica Cancer Care Santa Monica, California
Uchealth North Fort Collins, Colorado
Uniklinik Koeln (Aoer) Cologne,
Universitaetsklinikum Schleswig Holstein Campus Luebeck Lübeck,
Universitaetsklinikum Ulm Ulm,
Universitares Krebszentrum Leipzig Leipzig,
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden Dresden,
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of Arizona Cancer Center Tucson, Arizona
University of California San Diego (Ucsd) Moores Cancer Center La Jolla, California
University of Iowa Hospitals and Clinics Iowa City, Iowa
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Weill Cornell Medical College Newyork Presbyterian Hospital New York, New York
Yokohama Municipal Citizens Hospital Yokohama,

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pociredir

Call Center - clinicaltrials@fulcrumtx.com

NCT05169580
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Key
Inclusion Criteria:
* Participant is 18 to 65 years of age, inclusive at the time informed consent is obtained. * Documented SCD at the time of screening (S/S, S/β0, S/β+, and S/C only) as confirmed through review of medical records or HPLC. * Participants who meet at least one the following criteria:
• ≥4 to 10 episodes of SCD pain crisis over 12 months, or ≥2 to 5 over 6 months prior to screening
• ≥2 episodes of SCD pain crisis plus at least one of the following over previous 12 months: i) Acute chest syndrome (ACS) ii. Hepatic or splenic sequestration iii. Priapism
• ≥2 of the following events over the previous 12 months:i. ACS ii. Hepatic or splenic sequestration iii. Priapism
• Tricuspid regurgitant jet velocity (TRV) ≥ 3.0 meter/second(m/s) OR TRV ≥ 2.5 m/s + N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma level ≥ 160 picogram per milliliter; OR documented ongoing pulmonary hypertension diagnosed from previous echocardiogram or right-sided heart catheterization with mean pulmonary artery pressure \> 25 millimeter of mercury;
• SCD-related chronic kidney disease (CKD)
• Meet medical criteria to receive (e.g., post-cerebrovascular accident) but are contraindicated for chronic transfusions (e.g., alloimmunization, transfusion reactions) * Previous experience with Hydroxyurea (HU) but have shown to be unresponsive and/or intolerant or ineligible AND * Previous experience with a stable dose of voxelotor, crizanlizumab, and/ or L-glutamine but have shown to be unresponsive and/or intolerant or ineligible * Per Investigator's recommendation, participants may continue crizanlizumab and/or L-glutamine but must be on a stable dose for at least 6 months * HbF ≤ 20% of total Hb * Total Hb ≥ 5.5 g/dL and ≤ 12 g/dl (males) or ≤ 10.6 g/dl (females) at screening. * Participant must meet both of the following laboratory values at screening:
• Absolute neutrophil count ≥ 1.5 × 10\^9 per liter (/l)
• Platelets ≥ 80 × 10\^9/l
• Absolute reticulocyte count at screening ≥ 100 x 10\^9/l. Key
Exclusion Criteria:
* Sickle cell complication requiring care from a medical provider in hospital or emergency care setting in the 14 days prior to starting study drug. * History of bone marrow transplant or human stem cell transplant or gene therapies. * • Participants with a history of severe renal disease defined as estimated glomerular filtration rate \< 30 mL/min/1.73m\^2. Participants on dialysis of any kind are excluded. * Participants receiving regularly scheduled transfusions or therapeutic phlebotomies, or any participant who has been transfused within 60 days prior to initiating study drug. * Participant with active malignancy, or history of cancer (except for squamous cell skin cancer, basal cell skin cancer, and stage 0 cervical carcinoma in situ, with no recurrence for the last 5 years), or has an immediate family member with known or suspected familial cancer syndrome. Known presence of a chromosomal abnormality or genetic mutation that may put the participant at an increased risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). * Participant currently on HU, or have received HU, within 60 days prior to initiating study drug.
DRUG: Pociredir oral capsule(s)
Sickle Cell Disease, Sickle Cell Anemia
Sickle Cell Disease, Sickle Cell Anemia, Pharmacokinetics, Pharmacodynamics, Pociredir, Open label
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Atlanta Center for Medical Research Atlanta, Georgia
Augusta University Augusta, Georgia
Axon Clinical Research Institute Baltimore, Maryland
Barau Dikko Teaching Hospital Kaduna,
Boston Medical Center Boston, Massachusetts
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg,
Eastern Carolina University Greenville, North Carolina
Foundation for Sickle Cell Disease Research, LLC Hollywood, Florida
Inova Schar Cancer Institute Fairfax, Virginia
Jacobi Medical Center The Bronx, New York
Lynn Health Science Institute Oklahoma City, Oklahoma
Mississippi Center for Advanced Medicine Madison, Mississippi
National Hospital, Abuja Abuja,
Our Lady of the Lake Hospital Baton Rouge, Louisiana
Queens Hospital Cancer Center Jamaica, New York
Sonar Research Center Atlanta, Georgia
University of Arkansas for Medical Sciences (UAMS) Little Rock, Arkansas
University of California, Los Angeles Los Angeles, California
University of Ibadan Ibadan,
University of Illinois Chicago Chicago, Illinois
University of Miami Health System Miami, Florida
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Texas Houston Houston, Texas
Virginia Commonwealth University Richmond, Virginia
Visionaries Clinical Research Atlanta, Georgia

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

ctrrecruit@vcu.edu

NCT06577441
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Inclusion Criteria:
* GENERAL MYLEOMATCH REGISTRATION CRITERIA: * Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \[g-CSF\], thrombopoietin \[TPO\] agonist), lenalidomide or luspatercept is allowed with a maximum limit of 1 month of exposure. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN) * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Enasidenib
Myelodysplastic Syndrome
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Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
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)
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-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
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)
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 Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Geisinger Medical Center Danville, 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)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
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)
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)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Medical College of Wisconsin Milwaukee, Wisconsin
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mills Health Center San Mateo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
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)
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Parkland Health Center - Farmington Farmington, Missouri
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)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
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 Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
San Juan City Hospital San Juan,
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
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
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 Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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 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 Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
William S Middleton VA Medical Center Madison, Wisconsin

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Toll Free Number - Trialsites@msd.com

NCT06136559
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy. * Has at least 1 marker of disease burden. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization. * Has the ability to swallow and retain oral medication. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening. * Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection. * Has gastrointestinal (GI) dysfunction that may affect drug absorption. * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL. * Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening. * Has clinically significant cardiovascular disease. * Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients. * Has history of severe bleeding disorder. * Has known additional malignancy that is progressing or has required active treatment within the past 2 years. * Has received any systemic anticancer therapy for CLL/SLL. * Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors. * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration. * Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
DRUG: Nemtabrutinib, DRUG: Ibrutinib, DRUG: Acalabrutinib
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205) Mechelen, Antwerpen
Aalborg Universitetshospital, Syd ( Site 0403) Aalborg, North Denmark
Akershus Universitetssykehus ( Site 0902) Lørenskog, Akershus
Alta Bates Summit Medical Center ( Site 0004) Berkeley, California
Anhui Provincial Cancer Hospital ( Site 2001) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407) Ankara,
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401) Ankara,
Antalya Egitim ve Arastırma Hastanesi ( Site 1409) Antalya,
Aotearoa Clinical Trials ( Site 3201) Auckland,
Arizona Oncology Associates - NAHOA ( Site 8007) Prescott, Arizona
BC Cancer Kelowna ( Site 0112) Kelowna, British Columbia
BC Cancer Victoria ( Site 0109) Victoria, British Columbia
Barnet Hospital ( Site 3005) Barnet,
Bnai Zion Medical Center ( Site 1505) Haifa,
Bradfordhill-Clinical Area ( Site 2310) Santiago, Region M. de Santiago
Cancer Care Associates Of York ( Site 0005) York, Pennsylvania
Cancer Institute Hospital of JFCR ( Site 1906) Koto, Tokyo
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100) Rimouski, Quebec
Centro Medico Monte Carmelo-Oncology ( Site 2706) Arequipa, Ariqipa
Centro de Infusion Superare ( Site 2602) Mexico City, Mexico City
Champalimaud Foundation ( Site 3102) Lisbon, Lisbon District
Chang Gung Medical Foundation-Linkou Branch ( Site 1703) Taoyuan District,
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702) Kaohsiung City,
Chiba Cancer Center ( Site 1905) Chiba,
Chongqing University Cancer Hospital ( Site 2041) Chongqing, Chongqing Municipality
Chulalongkorn University ( Site 1802) Bangkok, Bangkok
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003) Nottingham,
Clermont Oncology Center ( Site 0046) Clermont, Florida
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306) Santiago, Region M. de Santiago
Clínica Anglo Americana ( Site 2701) Lima,
Constantiaberg Haematology ( Site 1106) Plumstead, Western Cape
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall, Pennsylvania
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids, Michigan
Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich, Connecticut
Ege Universitesi Hastanesi ( Site 1404) Izmir,
Evangelismos General Hospital of Athens ( Site 0700) Athens, Attica
FALP-UIDO ( Site 2300) Santiago, Region M. de Santiago
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801) Bangkok, Bangkok
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301) Hradec Králové,
Fakultni nemocnice Olomouc ( Site 0303) Olomouc,
Florida Cancer Specialists - East ( Site 7002) West Palm Beach, Florida
Florida Cancer Specialists - South ( Site 7001) Fort Myers, Florida
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402) Cali, Valle del Cauca Department
Galilee Medical Center ( Site 1507) Nahariya,
General Hospital of Athens "Laiko" ( Site 0704) Athens, Attica
GenesisCare - Bristol ( Site 3011) Bristol, South Gloucestershire
GenesisCare - Cambridge ( Site 3001) Newmarket, Suffolk
GenesisCare - Windsor ( Site 3002) Windsor, Windsor And Maidenhead
Groote Schuur Hospital-Clinical Haematology ( Site 1100) Cape Town, Western Cape
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) Nanning, Guangxi
Gunma University Hospital ( Site 1903) Maebashi, Gunma
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202) Barcelona, Catalonia
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208) Majadahonda, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209) Pozuelo de Alarcón, Madrid
Hadassah Medical Center-Hemato-Oncology ( Site 1500) Jerusalem,
Haemalife ( Site 1105) Kuilsriver, Western Cape
Hainan General Hospital ( Site 2018) Haikou, Hainan
Health Pharma Professional Research S.A. de C.V: ( Site 2608) Mexico City, Mexico City
Henan Cancer Hospital-hematology department ( Site 2025) Zhengzhou, Henan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913) Hiroshima,
Hokkaido University Hospital ( Site 1900) Sapporo, Hokkaido
Hospital 9 De Julho ( Site 2206) São Paulo, São Paulo
Hospital Paulistano-Americas Oncologia ( Site 2202) São Paulo,
Hospital Pulau Pinang ( Site 1602) George Town, Pulau Pinang
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206) Barcelona,
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201) Salamanca,
Hunan Cancer Hospital ( Site 2020) Changsha, Hunan
IMAT S.A.S ( Site 2401) Montería, Departamento de Córdoba
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606) Koblenz, Rhineland-Palatinate
Inova Schar Cancer Institute ( Site 0015) Fairfax, Virginia
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207) L'Hospitalet Del Llobregat, Barcelona
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005) Tianjin, Tianjin Municipality
Instituto Nacional de Câncer - INCA ( Site 2201) Rio de Janeiro,
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103) Lisbon, Lisbon District
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100) Porto,
Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction, Colorado
Japanese Red Cross Osaka Hospital ( Site 1908) Osaka,
Jiangsu Province Hospital ( Site 2000) Nanjing, Jiangsu
Jiangxi Provincial Cancer Hospital ( Site 2009) Nanchang, Jiangxi
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack, New Jersey
Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County
Kindai University Hospital ( Site 1909) Sayama, Osaka
Kliniken Maria Hilf ( Site 0603) Mönchengladbach, North Rhine-Westphalia
Kobe City Medical Center General Hospital ( Site 1910) Kobe, Hyōgo
Kyushu University Hospital ( Site 1914) Fukuoka,
Liuzhou People's Hospital ( Site 2029) Liuzhou, Guangxi
Lutheran Medical Center ( Site 0027) Golden, Colorado
Maharaj Nakorn Chiang Mai Hospital ( Site 1800) Muang, Chiang Mai
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408) Istanbul,
McGill University Health Centre ( Site 0106) Montreal, Quebec
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010) Spokane, Washington
Mega Medipol ( Site 1412) Istanbul,
MidAmerica Cancer Care, LLC ( Site 0043) Kansas City, Missouri
Moores Cancer Center ( Site 0003) La Jolla, California
Nagoya University Hospital ( Site 1907) Nagoya, Aichi-ken
Naresuan University Hospital ( Site 1804) Muang, Changwat Phitsanulok
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004) Warsaw, Masovian Voivodeship
National Cheng Kung University Hospital ( Site 1700) Tainan,
National Taiwan University Hospital ( Site 1701) Taipei,
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101) Pretoria, Gauteng
North Shore Hospital-Department of Haematology ( Site 3200) Auckland,
Odense Universitetshospital-Department of Hematology ( Site 0401) Odense C, Region Syddanmark
Okayama University Hospital ( Site 1912) Okayama,
Oncology Specialists of Charlotte ( Site 0054) Charlotte, North Carolina
Ondokuz Mays Üniversitesi ( Site 1410) Samsun,
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600) Berlin,
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901) Oslo,
Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne, Indiana
Peking University First Hospital ( Site 2022) Beijing, Beijing Municipality
Peking University Third Hospital-Hematology ( Site 2011) Beijing, Beijing Municipality
Pratia MCM Krakow ( Site 1007) Krakow, Lesser Poland Voivodeship
Pratia Onkologia Katowice ( Site 1009) Katowice, Silesian Voivodeship
Queen Elizabeth Hospital ( Site 1603) Kota Kinabalu, Sabah
Queen Mary Hospital ( Site 3300) Hong Kong,
Rabin Medical Center ( Site 1504) Petah Tikva,
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503) Haifa,
Regions Hospital ( Site 0042) Saint Louis Park, Minnesota
Roskilde Sygehus-Department of Hematology ( Site 0402) Roskilde, Region Sjælland
Roswell Park Cancer Institute ( Site 0023) Buffalo, New York
Royal Lancaster Infirmary ( Site 3012) Lancaster, Lancashire
Royal North Shore Hospital ( Site 2806) St Leonards, New South Wales
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048) Madison, Wisconsin
Saint Elizabeth Healthcare ( Site 0041) Edgewood, Kentucky
Saint Joseph Hospital ( Site 0026) Denver, Colorado
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005) Olsztyn, Warmian-Masurian Voivodeship
Shaanxi provincial people's hospital ( Site 2012) Xi'an, Shaanxi
Shandong Cancer Hospital ( Site 2003) Jinan, Shandong
Shanxi Cancer Hospital ( Site 2033) Taiyuan, Shanxi
Sheba Medical Center-Hemato Oncology ( Site 1501) Ramat Gan,
Shimane University Hospital ( Site 1911) Izumo, Shimane
Sisli Florence Nightingale Hastanesi ( Site 1411) Istanbul,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405) Valledupar, Cesar Department
Songklanagarind hospital ( Site 1803) Hat Yai, Changwat Songkhla
Southeastern Medical Oncology Center ( Site 0049) Goldsboro, North Carolina
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) Guangzhou, Guangdong
Southmead Hospital ( Site 3010) Bristol, Bristol, City of
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006) London, London, City of
St James's University Hospital ( Site 3004) Leeds,
Summit Medical Group Cancer Center ( Site 0007) Florham Park, New Jersey
Sun Yat-sen University Cancer Center ( Site 2028) Guangzhou, Guangdong
Sykehuset i Vestfold ( Site 0903) Tønsberg, Vestfold
TENNESSEE ONCOLOGY ( Site 0031) Nashville, Tennessee
Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga, Tennessee
Texas Oncology - Central/South Texas ( Site 8008) Austin, Texas
Texas Oncology - Northeast Texas ( Site 8012) Tyler, Texas
Texas Oncology - San Antonio ( Site 8006) San Antonio, Texas
The Affiliated Hospital of Guizhou Medical University ( Site 2024) Guiyang, Guizhou
The Affiliated Hospital of Xuzhou Medical College ( Site 2013) Xuzhou, Jiangsu
The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth, Texas
The Churchill Hospital ( Site 3007) Oxford, Oxfordshire
The First Affiliated Hospital of Nanchang University ( Site 2023) Nanchang, Jiangxi
The First Affliated Hospital of Suzhou University ( Site 2027) Suzhou, Jiangsu
The First Hospital of Jilin University-Hematology ( Site 2030) Changchun, Jilin
The Ottawa Hospital - General Campus ( Site 0102) Ottawa, Ontario
The Second Xiangya Hospital of Central South University ( Site 2010) Changsha, Hunan
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002) Hangzhou, Zhejiang
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019) Tianjin, Tianjin Municipality
Tohoku University Hospital ( Site 1901) Sendai, Miyagi
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016) Wuhan, Hubei
Trakya University-Balkan Onkoloji Hastanesi ( Site 1403) Edirne,
USA Mitchell Cancer Institute ( Site 0014) Mobile, Alabama
UZ Leuven-Hematology ( Site 0200) Leuven, Vlaams-Brabant
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107) Vila Nova de Gaia, Porto District
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104) Lisbon,
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106) Lisbon,
Universitaetsklinikum Ulm. ( Site 0601) Ulm, Baden-Wurttemberg
University Hospital and UW Health Clinics ( Site 0006) Madison, Wisconsin
University Hospital of Alexandroupolis ( Site 0701) Alexandroupoli, East Macedonia and Thrace
University Hospital of Ioannina ( Site 0702) Ioannina,
University Malaya Medical Centre ( Site 1604) Lembah Pantai, Kuala Lumpur
University of Iowa-Holden Comprehensive Cancer Center ( Site 0017) Iowa City, Iowa
University of Virginia Cancer Center ( Site 0040) Charlottesville, Virginia
Universitätsklinikum Halle ( Site 0604) Halle, Saxony-Anhalt
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006) Lublin, Lublin Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011) Gdansk, Pomeranian Voivodeship
VK&K Studien GbR ( Site 0607) Landshut, Bavaria
Virginia Commonwealth University (VCU) Medical Center ( Site 0030) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) Prague,
Waikato Hospital-Haematology ( Site 3202) Hamilton, Waikato Region
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026) Chengdu, Sichuan
William Osler Health System ( Site 0103) Brampton, Ontario
Wits Clinical Research ( Site 1102) Johannesburg, Gauteng
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013) Słupsk, Pomeranian Voivodeship
Wuhan Union Hospital ( Site 2015) Wuhan, Hebei
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014) Ürümqi, Xinjiang
Yamagata University Hospital ( Site 1902) Yamagata,
Yitzhak Shamir Medical Center. ( Site 1506) Ẕerifin,
Zhejiang Cancer Hospital ( Site 2017) Hangzhou, Zhejiang
hospital universitario de canarias ( Site 1205) San Cristóbal de La Laguna, Santa Cruz De Tenerife

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD)

Daiichi Sankyo Contact for Clinical Trial Information - CTRinfo_us@daiichisankyo.com

NCT06578247
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Key
Inclusion Criteria:

• Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
• ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
• Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
• Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
• Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key
Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
• Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
• Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
• Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
• Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
• Leukapheresis;
• Treatment for hyperleukocytosis with hydroxyurea;
• Cranial radiotherapy for central nervous system (CNS) leukostasis;
• Prophylactic intrathecal chemotherapy
DRUG: Quizartinib, DRUG: Placebo, DRUG: Chemotherapy
Leukemia
acute myeloid leukemia, quizartinib, FLT3, FLT3-ITD, Chemotherapy, FLT3-WT
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Study Locations

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Location Contacts
'Shathd' Ead Sofia Sofia,
AZ Delta Roeselare,
AZ Sint-Jan Bruges,
Affiliated Hospital of Nantong University Nantong,
Ajou University Hospital Gyeonggi-do,
Akademiska Sjukhuset Uppsala,
Akita University Hospital Akita,
Aomori Prefetural Central Hospital Aomori,
Asan Medical Center Seoul,
Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese Varese,
Augusta University Augusta, Georgia
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Rome,
Azienda Ospedaliera Vincenzo Cervello Palermo,
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari, Apulia
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino,
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Milan,
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia,
Box Hill Hospital Box Hill, Victoria
CHU Amiens - Hopital Sud Salouël,
CHU Nice - Hôpital de l'Archet 1 Nice,
CHU de Caen Caen,
CHU de Nantes - Hotel Dieu Nantes,
Centre Hospitalier Lyon Sud Pierre-Bénite,
Centre Hospitalier de Versailles Le Chesnay,
Centre Leon Berard Lyon,
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria Lisbon,
Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp Campinas,
Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp Campinas,
Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina Florianópolis,
Cetus Hospital Dia Oncologia Belo Horizonte,
Chang Gung Memorial Hospital Kaohsiung City,
Chiba Aoba Municipal Hospital Chiba,
China Medical University Hospital Taichung,
Chonnam National University Hwasun Hospital Jeollanam-do,
Chu Angers - Hă"Pital Hă"Tel Dieu Angers,
Chu Rennes - Hopital Pontchaillou Rennes,
Chu de Bordeaux - Hă"Pital Haut-Lă Vă Que Pessac,
Chu de Grenoble - Hospital Albert Michallon La Tronche,
Chu of Liège Liège,
Chugoku Central Hospital Fukuyama,
Churchill Hospital Oxford,
City of Hope Phoenix Goodyear, Arizona
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio
Clinica Universidad de Navarra Madrid,
Clinical Hospital Centar Zagreb Zagreb,
Clinical Hospital Centre Rijeka Rijeka,
Clinical Hospital Dubrava Zagreb,
Colorado Blood Cancer Institute Denver, Colorado
Complejo Hospitalario Universitario de Albacete Albacete,
Complejo Hospitalario Universitario de Santiago Santiago de Compostela,
Concord Repatriation General Hospital Concord, New South Wales
Curie Oncology Pte Ltd Singapore,
Daegu Catholic University Medical Center Daegu,
Debreceni Egyetem Debrecen,
Duke Cancer Institute - Sarcoma Research Durham, North Carolina
Ehime Prefectural Central Hospital Matsuyama,
Fakultni Nemocnice Ostrava Ostrava - Poruba,
Fakultni nemocnice Brno Brno,
Fakultni nemocnice Hradec Kralove Hradec Králové,
Fakultni nemocnice Kralovske Vinohrady Prague,
Fakultni nemocnice Plzen Pilsen, Plzeň Region
Fiona Stanley Hospital Murdoch,
Flinders Medical Centre (Fmc) Bedford Park,
Florida Hospital Cancer Institute - Kissimmee Kissimmee, Florida
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma,
Fundaã§Ã£O Doutor Amaral Carvalho Jaú,
Fundação Doutor Amaral Carvalho Jaú,
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto,
Gachon University Gil Medical Center Incheon,
Gifu Municipal Hospital Gifu,
Guangdong Provincial People's Hospital Guangzhou,
Guangdong Provincial People's Hospital Guangzhou,
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr,
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia,
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Fortaleza,
Hackensack University Medical Center Hackensack, New Jersey
Hamamatsu University School of Medicine, University Hospital Hamamatsu,
Hammersmith Hospital London,
Hanusch Krankenhaus Der Wgkk Wien Vienna,
Haukeland Universitetssykehus Bergen,
Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S Goiânia,
Henan Cancer Hospital Zhengzhou,
Henry Ford Hospital Detroit, Michigan
Hokkaido University Hospital Sapporo, Hokkaido
Hopital Claude Huriez - Chru Lille Lille,
Hopital de la Conception - APHM Marseille,
Hospital Beneficencia Portuguesa da Sao Paulo São Paulo,
Hospital Clinico Universitario de Valencia Valencia,
Hospital De La Santa Creu I Sant Pau Barcelona,
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer Curitiba,
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba,
Hospital Ernesto Dornelles Porto Alegre,
Hospital General Universitario Morales Meseguer Murcia,
Hospital Nove de Julho São Paulo,
Hospital Regional Universitario de Malaga Málaga,
Hospital Saint-Louis Paris,
Hospital San Pedro de Alcantara Cáceres,
Hospital Universitari Son Espases Palma,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitari i Politécnic La Fe Valencia,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Dr. Peset Valencia,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda,
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Reina Sofia Córdoba,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Burgos Burgos,
Hospital Universitario de Gran Canaria Dr. Negrin Las Palmas,
Hospital de Clinicas de Passo Fundo Passo Fundo,
Hospital de Clă Nicas de Passo Fundo Passo Fundo,
Hospital de Clă Nicas de Porto Alegre Porto Alegre,
Houston Methodist Hospital Houston, Texas
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo,
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo,
INCA - Instituto Nacional de Câncer Rio de Janeiro,
IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo,
Ico Badalona - Hospital Universitari Badalona,
Inje University Haeundae Paik Hospital Haeundae-Gu,
Inselspital - Universitaetsspital Bern Bern,
Institut Jules Bordet Anderlecht,
Institut Universitaire Du Cancer de Toulouse- Iuct-O Toulouse,
Institut de Cancă Rologie de Strasbourg Europe - Icans Strasbourg,
Institute of Hematology and Hospital of Blood Disease Tianjin, Tianjin Municipality
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto,
Institutul Clinic Fundeni Bucharest,
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj-Napoca,
Instytut Hematologii I Transfuzjologii Warsaw,
Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst Meldola,
Istituto Clinico Humanitas Rozzano,
Japan RED CROSS OSAKA HOSPITAL Osakar,
Jeonbuk National University Hospital Jeonju,
Johns Hopkins Hospital Baltimore, Maryland
KRH Klinikum Siloah Hanover,
Kanazawa University Hospital Kanazawa,
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City,
King's College Hospital London, London, City of
Klinika Hematoonkologii I Transplantacji Szpiku Lublin,
Klinikum Aschaffenburg-Alzenau Alzenau in Unterfranken,
Korea University Guro Hospital Seoul,
Kyungpook National University Chilgok Hospital Daegu,
Kyushu University Hospital Fukuoka,
LKH - Universitätsklinikum der PMU Salzburg Salzburg,
Liverpool Hospital Liverpool,
London Health Sciences Centre London, Ontario
Luzerner Kantonsspital - Luzern Lazern 16,
Maidstone Hospital Maidstone,
Manchester Royal Infirmary Manchester,
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Mayo Clinic - Phoenix Phoenix, Arizona
Mayo Clinic Hospital Phoenix, Arizona
Md Anderson Cancer Centre Madrid,
Medical College of Wisconsin Milwaukee, Wisconsin
Memorial Sloan Kettering Cancer Center - Main New York, New York
Military Medical Academy Belgrade,
Military Medical Academy - Mhat - Sofia Sofia,
Moffitt Cancer Center Tampa, Florida
Nagoya University Hospital Showa-Ku Nagoya,
National Cheng Kung University Hospitalx Tainan City,
National Hospital Organization Kumamoto Medical Center Kumamoto,
National Taiwan University Hospital Taipei,
National University Hospital Kent Ridge,
Ochsner Medical Center - New Orleans New Orleans, Louisiana
Ohio Health Marion Area Physicians Columbus, Ohio
Ordensklinikum Linz Gmbh - Elisabethinen Linz,
Oregon Health & Science University (OHSU) Portland, Oregon
Oslo University Hospital Oslo,
Ospedale Maggiore di Novara Novara,
Ospedale Mauriziano Umberto I Torino,
Ospedale San Raffaele Milan,
Peggy & Charles Stephenson Oklaho Oklahoma City, Oklahoma
Peking Union Medical College Hospital Beijing,
Peking University First Hospital Beijing,
Peking University Third Hospital Beijing,
Princess Alexandra Hospital Woolloongabba, Queensland
Princess Margaret Cancer Center Toronto,
Pusan National University Hospital Busan,
Qilu Hospital of Shandong University Jinan, Shandong
Rhode Island Hospital Providence, Rhode Island
Robert H Lurie Comprehensive Cancer Center Northwestern University Chicago, Illinois
Roswell Park Comprehensive Cancer Center Buffalo, New York
Royal Adelaide Hospital Adelaide,
Sahlgrenska Universitetssjukhuset Gothenburg,
Saiseikai Maebashi Hospital Maebashi,
Samsung Medical Center Seoul,
Santa Casa de Misericordia de Porto Alegre Porto Alegre,
Sapporo Hokuyu Hospital Hokkaido,
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Semmelweis Egyetem Budapest,
Seoul National University Bundang Hospital Seongnam-si,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shanghai Tongren Hospital Shanghai,
Shengjing Hospital of China Medical University Shenyang,
Shenzhen Second People'S Hospital Shenzhen,
Sir Charles Gairdner Hospital Perth,
Skă Nes Universitetssjukhus, Lund Lund,
South Austin Medical Center Austin, Texas
Spitalul Clinic Colentina Bucharest,
Spitalul Clinic Coltea Bucharest,
Spitalul Clinic Municipal Filantropia Craiova Craiova,
Spzoz Msw Zwarmiĺ Sko-Mazurskimcen.Onko.Wolsztynie Olsztyn,
St Vincent's Hospital Melbourne Fitzroy,
Staedtisches Klinikum Braunschweig Ggmbh Braunschweig,
Stanford University School of Medicine- Parent Stanford, California
Sun Yat-Sen University, Cancer Center Guangzhou,
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged,
Taipei Veterans General Hospital Taipei,
Tampa General Hospital Tampa, Florida
Tenri Hospital Tenri-Shi,
Tesshokai Kameda General Hospital Kamogawa-shi,
The Affiliated Hospital of Qingdao University Shandong,
The Alfred Hospital Melbourne, Victoria
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul,
The Chinese University of Hong Kong (Cuhk) Shatin,
The First Affiliated Hospital of Chongqing Medical University Chongqing, Chongqing Municipality
The First Affiliated Hospital of NanChang University Nanchang,
The First Affiliated Hospital of Soochow University Suzhou,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Xiâ An Jiaotong University Xi'an,
The James Cancer Hospital and Solove Research Institute Columbus, Ohio
The Ottawa Hospital - General Campus Ottawa,
The Second Hospital of Hebei Medic Shijiazhuang,
The Second Xiangya Hospital of Central South University Changsha,
The University of Chicago Medical Center Chicago, Illinois
The University of Hong Kong Hong Kong,
The University of Texas MD Anderson Cancer Center Houston, Texas
Thomas Jefferson Univ Hosp Philadelphia, Pennsylvania
Tianjin Medical University General Hospital Tianjin, Tianjin Municipality
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo,
Torbay Hospital Torquay,
Townsville University Hospital Douglas,
Tristar Bone Marrow Transplant Nashville, Tennessee
UMHAT 'Dr. Georgi Stranski', EAD Pleven,
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
UZ Leuven Leuven,
Ucsf - School of Medicine San Francisco, California
Ulsan University Hospital Ulsan,
Umhat 'Sv. Georgi', Ead Plovdiv,
Umhat Prof. Dr. Stoyan Kirkovich Ad Stara Zagora,
Umhat  Sv. Ivan Rilskiâ , Ead Sofia,
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu Botucatu,
UniversitaetsKlinikum Heidelberg Heidelberg,
Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden,
Universitaetsklinikum Essen Essen,
Universitaetsklinikum Muenster Münster,
Universitaetsklinikum Schleswig-Holstein Kiel,
University Clinical Center Nis Niš,
University Clinical Center of Serbia Belgrade,
University Hospital of North Norway Tromsø,
University of Arizona Cancer Center Tucson, Arizona
University of Cincinnati Cincinnati, Ohio
University of Illinois Hospital & Health Sciences System Chicago, Illinois
University of Kentucky Lexington, Kentucky
University of Michigan Comprehensive Cancer Center Michigan Medicine Ann Arbor, Michigan
University of Minnesota Medical School - Twin Cities Campus Minneapolis, Minnesota
University of North Carolina Hospitals Chapel Hill, North Carolina
University of Pennsylvania Philadelphia, Pennsylvania
Universită"Tsklinikum Leipzig Klinik Fă R Hă"Matologie Internistische Onkologie Hă"Mostaseol Leipzig,
Upstate University Hospital Syracuse, New York
Ustav Hematologie A Krevni Transf Prague,
Uva Health System Charlottesville, Virginia
Virginia Commonwealth University (VCU) Massey Cancer Center Richmond, Virginia
Washington University St Louis, Missouri
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Torun,
Wuxi People's Hospital Wuxi, Jiangsu
Xiangya Hospital, Central South University Changsha,
Yale University New Haven, Connecticut
Yantai Yuhuangding Hospital Yantai, Shandong
Yeungnam University Hospital Daegu,
ZNA Antwerp,
Zhong Da Hospital, Southeast University Nanjing,
the First Hospital of Jilin University Changchun,