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106 Study Matches
Genome Transplant Dynamics (GTD NIH)
Sean T Agbor-Enoh, M.D. - agborenohst@mail.nih.gov
Shah, Keyur, B
NCT02423070
HM20004684
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* INCLUSION CRITERIA:
* Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.
* Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
* 14 years and older
* Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
* Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.
EXCLUSION CRITERIA:
-Pregnancy
Thoracic Organ Transplantation
Cell-free DNA, Acute Rejection, Thoracic Organ Transplantation, Non-Invasive Testing, Chronic Rejection, Natural History
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Study Locations
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| Location | Contacts |
|---|---|
| INOVA Fairfax Medical Falls Church, Virginia | Steven Nathan, M.D. - (steven.nathan@inova.org) |
| Johns Hopkins University Baltimore, Maryland | Jonathan Orens, M.D. - (jorens@jhmi.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| National Institutes of Health Clinical Center Bethesda, Maryland | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) - (ccopr@nih.gov) |
| University of Maryland Towson, Maryland | |
| Virginia Commonwealth University Richmond, Virginia |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Elizabeth Fosberg, B.A. - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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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 | Matthew Ulrickson, MD - (Matthew.Ulrickson@bannerhealth.com) |
| Beth Israel Deaconess Boston, Massachusetts | David Avigan, MD - (davigan@bidmc.harvard.edu) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Deepika Bhatla, MD - (dbhatla@slu.edu) |
| Children's Healthcare of Atlanta Atlanta, Georgia | 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 | |
| Children's Hospital at Montefiore The Bronx, New York | Mahvish Rahim, MD - (mrahim@montefiore.org) |
| Children's Hospital of Los Angeles Glendale, 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 | Timothy Olson, MD - (olsont@email.chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Paul Szabolcs, MD - (Paul.szabolcs@chp.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | David Margolis, MD - (dmargoli@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu) |
| Children's Mercy Hospital and Clinics Kansas City, Missouri | Erin Hall, MD - (emhall@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | David Jacobsohn, MD - (dajacobs@childrensnational.org) |
| Childrens Hospital Medical Center of Akron Akron, Ohio | Megan Sampson, MD - (msampson@akronchildrens.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Stella Davies, MD - (stella.davies@cchmc.org) |
| City of Hope Duarte, California | Monzr Al Malki, MD - (malmalki@coh.org) |
| Cleveland Clinic Cleveland, Ohio | Claudio Brunstein, MD - (brunstc@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde, New York | Jonathan Fish, MD - (jfish1@nshs.edu) |
| Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York | Monica Bhatia, MD - (mb2476@columbia.edu) |
| Cook Children's Hospital Fort Worth, Texas | Gretchen Eames, MD - (gretchen.eames@cookchildrens.org) |
| Dana Farber Cancer Institute Boston, Massachusetts | Corey Cutler, MD - (cscutler@partners.org) |
| Duke University Medical Center Durham, North Carolina | Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu) |
| Emory University Hospital Atlanta, Georgia | |
| Florida Center for Pediatric Cellular Therapy Orlando, Florida | Susan Kelly, MD - (susan.kelly.md@flhosp.org) |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Ann Dahlberg, MD - (adahlber@fredhutch.org) |
| Georgia Cancer Center at Augusta University Health Augusta, Georgia | Vamsi K Kota, MD - (vkota@augusta.edu) |
| Greenebaum Cancer Center - University of Maryland Baltimore, Maryland | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | Alfred Gillio, MD - (agillio@humed.com) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Troy Quigg, MD - (troy.quigg@spectrumhealth.org) |
| Henry Ford Health System Detroit, Michigan | Nalini Janakiraman, MD - (njanaki1@hfhs.org) |
| Indiana Blood & Marrow Transplantation Beech Grove, Indiana | |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | Jodi Skiles, MD - (jskiles@iupui.edu) |
| Johns Hopkins Baltimore, Maryland | Allen Chen, MD, PhD - (allenchen@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Randal Wada, MD - (randalw@hawaii.edu) |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Children's Hospital Charlotte, North Carolina | Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org) |
| Loma Linda University Cancer Center Loma Linda, California | Hisham Abdel-Azim, MD - (habdelazim@llu.edu) |
| Loyola University Medical Center Maywood, Illinois | Patrick Hagen, MD - (patrick.hagen@lumc.edu) |
| M.D. Anderson Cancer Center Houston, Texas | Elizabeth Shpall, MD - (eshpall@mdanderson.org) |
| Massachusetts General Hospital Lexington, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| Mayo Clinic Arizona (adults) Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical City Dallas Dallas, Texas | Vikas Bhushan, MD - (vikas.bhushan@usoncology.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Michelle Hudspeth, MD - (hudspeth@musc.edu) |
| Memorial Sloan-Kettering Cancer Center New York, New York | Ann Jakubowski, MD - (jakubowa@mskcc.org) |
| Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee | |
| Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas | Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Medical Center - New York New York, New York | Alla Keyzner, MD - (alla.keyzner@mssm.edu) |
| NIH/NCI Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org) |
| Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware | Emi Caywood, MD - (ecaywood@nemours.org) |
| Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida | Edward Ziga, MD - (Edward.ziga@nemours.org) |
| New York Presbyterian Hospital at Cornell New York, New York | Tsiporah Shore, MD - (tbs2001@med.cornell.edu) |
| New York University Langone Medical Center New York, New York | Mohammad M Abdul Hay, MD - (maher.abdulhay@nyulangone.org) Antoine Mesidor - (Antoine.Mesidor@nyulangone.org) |
| Nih/Nhlbi Bethesda, Maryland | Richard Childs, MD - (childsr@nih.gov) |
| Nih/Niaid Bethesda, Maryland | Elizabeth Kang, MD - (ekang@niaid.nih.gov) |
| Niklaus Children's Hospital Miami, Florida | Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org) |
| North Shore University Hospital Manhasset, New York | Ruthee L Bayer, MD - (rbayer@nshs.edu) |
| Northside Hospital Atlanta, Georgia | Scott Solomon, MD - (ssolomon@bmtga.com) |
| Northwestern Memorial Hospital Chicago, Illinois | Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu) |
| Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon | Eneida Nemecek, MD - (nemeceke@ohsu.edu) |
| Orlando Health Arnold Palmer Hospital for Children Orlando, Florida | Rikin Shah - (rikin.shah@orlandohealth.com) |
| Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy Orlando, Florida | Yasser Khaled, MD - (yasser.khaled@orlandohealth.com) |
| Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania | Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Dana Salzberg, MD - (dsalzberg@phoenixchildrens.com) |
| Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado | Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com) |
| Rady Children's Hospital San Diego San Diego, California | Eric Anderson, MD - (eanderson@rchsd.org) |
| Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey | Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu) |
| Roger Williams Medical Center Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | Kanwaldeep Mallhi, MD - (Kanwaldeep.Mallhi@RoswellPark.org) |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon BMT Program Nashville, Tennessee | |
| Scripps Green Hospital La Jolla, California | James R Mason, MD - (mason.james@scrippshealth.org) |
| Southwest Cancer Treatment & Research Center Lubbock, Texas | |
| Spectrum Health Grand Rapids, Michigan | Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org) |
| St. Jude Childrens Research Hospital Memphis, Tennessee | Renee Madden, MD - (renee.madden@stjude.org) |
| St. Louis University Medical Center St Louis, Missouri | |
| Stanford University Medical Center Palo Alto, California | Andrew Rezvani, MD - (arezvani@stanford.edu) |
| Stony Brook University Hospital Stony Brook, New York | Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu) |
| Strong Memorial Hospital/University of Rochester Rochester, New York | Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu) |
| Sutter Medical Center Sacramento, California | Elias Kiwan, MD - (elias.kiwan@sutterhealth.org) |
| Texas Children's Hospital - Baylor Medical Center Houston, Texas | George Carrum, MD - (gcarrum@houstonmethodist.org) |
| The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio | Sumithira Vasu, MD - (sumithira.vasu@osumc.edu) |
| The Children's Hospital of San Antonio San Antonio, Texas | Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org) |
| The Jewish Hospital Cincinnati, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org) |
| Tulane Medical Center New Orleans, Louisiana | |
| UCLA Los Angeles, California | Gary Schiller, MD - (gschiller@mednet.ucla.edu) |
| UCSF (adults) San Francisco, California | |
| UCSF (peds) San Francisco, California | Sandhya Kharbanda, MD - (sandhya.kharbanda@ucsf.edu) |
| Univeristy of Mississippi Medical Center Jackson, Mississippi | Carter Milner, MD - (capayne@umc.edu) |
| University Hospitals Case Medical Center Cleveland, Ohio | Hillard Lazarus, MD - (hillard.lazarus@case.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Joseph Chewning, MD - (jchewning@peds.uab.edu) |
| University of Arizona Medical Center - Tucson Tucson, Arizona | Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu) |
| University of California San Diego La Jolla, California | Kaitlyn Dykes, MD - (kcdykes@health.ucsd.edu) |
| University of Chicago Chicago, Illinois | James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu) |
| University of Colorado Hospital Aurora, Colorado | Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu) |
| University of Florida Shands Medical Center Gainesville, Florida | Jordan Milner, MD - (jordan.milner@ufl.edu) |
| University of Illinois at Chicago Chicago, Illinois | Damiano Rondelli, MD - (drond@uic.edu) |
| University of Iowa Iowa City, Iowa | Margarida Silverman, MD - (margarida-silverman@uiowa.edu) |
| University of Kansas Westwood, Kansas | Joseph McGuirk, DO - (jmcguirk@kumc.edu) |
| University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky | Mohamed Hegazi, MD - (mohamed.hegazi@louisville.edu) |
| University of Massachusetts Worcester, Massachusetts | |
| University of Miami (adult) Miami, Florida | |
| University of Miami (peds) Miami, Florida | Edward Ziga, MD, MPH - (e.ziga@med.miami.edu) |
| University of Michigan Ann Arbor, Michigan | Jessica Yu - (jjxyu@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Phyllis Warkenton, MD - (pwarkent@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Anson Snow, MD - (Anson.Snow@unchealth.unc.edu) |
| University of Oklahoma Health Science Center Oklahoma City, Oklahoma | Adam Asch, MD - (adam-asch@ouhsc.edu) |
| University of Pennsylvania/Thomas Jefferson Pittsburgh, Pennsylvania | Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Alison Sehgal, MD - (sehgalar@upmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Utah Salt Lake City, Utah | Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu) |
| University of Wisconsin - Madison Madison, Wisconsin | Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu) |
| VA Puget Sound HCS Seattle, Washington | |
| VA Tennessee Valley Healthcare System Nashville, Tennessee | |
| Vanderbilt University Nashville, Tennessee | Michael Byrne, MD - (michael.byrne@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | John McCarty, MD - (jmccarty@vcu.edu) |
| Wake Forest University Winston-Salem, North Carolina | |
| Washington University St. Louis St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| Washington University/St. Louis Children's Hospital St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| West Penn Hospital Pittsburgh, Pennsylvania | Prerna Mewawalla, MD - (pmewawalla26085@direct.ahn.org) |
| West Virginia University Morgantown, West Virginia | Lauren Veltri, MD - (lveltri@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Mitchell Cairo, MD - (mitchell_cairo@nymc.edu) |
| Yale New Haven Hospital New Haven, Connecticut | Aaron Flagg, MD - (aron.flagg@yale.edu) |
| Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas | Gilbert Ancira, MD - (gilbert.p.ancira.mil@health.mil) |
Project: Every Child for Younger Patients With Cancer (EVERYCHILD)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT02402244
HM20006485
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Inclusion Criteria:
* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
* All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
* All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
* All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant
* The following other benign/borderline conditions:
* Mesoblastic nephroma
* Teratomas (mature and immature types)
* Myeloproliferative diseases including transient myeloproliferative disease
* Langerhans cell histiocytosis
* Lymphoproliferative diseases
* Desmoid tumors
* Gonadal stromal cell tumors
* Neuroendocrine tumors including pheochromocytoma
* Melanocytic tumors, except clearly benign nevi
* Ganglioneuromas
* Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit
* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
* If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1 OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
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Show 278 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Brooke Army Medical Center Houston, Texas | |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Drexel University School of Medicine Philadelphia, Pennsylvania | |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (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 | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | 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) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| 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 | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| 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) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| 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) |
| 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 | |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (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) |
| Royal Hobart Hospital Saint Hobart, Tasmania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| 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 John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
| 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) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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) |
| 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 | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| 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) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT 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 Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | Site Public Contact - (jrhartl1@txch.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (cywhs.oncsec@health.sa.gov.au) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Pathway to Prevention Study
Memoli, Erica, H - erica.memoli@vcuhealth.org
Nelson, Bryce
NCT00097292
HM20012389
Endocrine, Nutritional And Metabolic Diseases, And Immunity Disorders, Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Memoli, Erica, H - (erica.memoli@vcuhealth.org) |
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com
McCarty, John, M.
NCT03435796
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Inclusion Criteria:
• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
• Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
Not Applicable
Other protocol-defined inclusion/exclusion criteria apply
Genetic: Gene-modified (GM) T cell therapy
Neoplasms
Long-term follow up, Gene-Modified T Cells, CAR T Cell
I'm interested
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See this study on ClinicalTrials.gov
Show 217 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien Wien, | |
| Arizona Cancer Center Scottsdale, Arizona | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino, Piedmont | |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi Bologna, | |
| Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette Turin, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Baptist Cancer Center Memphis, Tennessee | |
| Baylor Scott and White Health Temple, Texas | |
| CHRU de Lille France Lille Cedex, | |
| CHU Hotel Dieu Nantes Cedex 01, | |
| CHU La Miletrie Poitiers Cedex, | |
| CHU Montpellier - Hôpital Saint Eloi Montpellier CEDEX 5, | |
| CIUSSS de l'Est-de-l'Ile-de-Montreal Montreal, Quebec | |
| Cancer Center Of Kansas Wichita, Kansas | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Lyon-Sud Pierre-Bénite, | |
| Charite -Universitätsmedizin Berlin Berlin, | |
| Christie Hospital NHS Trust Manchester, | |
| City of Hope Duarte, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Cleveland Clinic Foundation Cleveland, Ohio | Brian Hill, Site 01062 |
| Clinica Universidad de Navarra Pamplona, Navarre | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Columbia University Medical Center/New York-Presbyterian Hospital New York, New York | |
| Dana-Farber/Mass General Brigham Cancer Care, Inc Boston, Massachusetts | |
| Duke University Medical Center Durham, North Carolina | |
| Erasmus Medical Center - Daniel den Hoed Rotterdam, | |
| Florida Hospital Transplant Institute Orlando, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milan, | |
| Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) Monza, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT) Indianapolis, Indiana | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Jordan Gauthier, Site 01110 |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | Meera Mohan, Site 01178 |
| Gustave Roussy Villejuif, X | |
| H. Lee Moffitt Cancer Center and Research Institute University of South Florida Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helsinki University Central Hospital (HUCH) Helsinki, | |
| Hematology Oncology and clinical immunology / Heinrich-Heine-University Dusseldorf, | |
| Hematology and Oncology Associates of SC, LLC Greenville, South Carolina | |
| Hematology and Oncology Associates of SC, LLC Greenville, South Carolina | Saeeda Chowdhury, Site 01034 |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Robert Debre Valence, | |
| Hopital Saint Louis Paris, | |
| Hopitaux de La Timone Marseille, Bouches-du-Rhône | |
| Hospital 12 de Octubre Madrid, | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Saint Louis Paris, | |
| Hospital San Joan de Deu Barcelona Esplugues de Llobregat, | |
| Hospital Universitari Germans Trias i Pujol ICO Badalona Barcelona, | |
| Hospital Universitario Vall D Hebron Barcelona, | |
| Hospital Virgen del Rocio Seville, | |
| IN Univ Simon Cancer Center Indianapolis, Indiana | |
| IN Univ Simon Cancer Center Indianapolis, Indiana | Rafat Abonour, Site 01161 |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Illinois Cancer Specialists Niles, Illinois | |
| Inselspital Bern Bern, | |
| Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona Barcelona, | |
| Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region | |
| Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse, Haute-Garonne | |
| Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center Lyon, | |
| Intermountain Healthcare - LDS Hospital Salt Lake City, Utah | |
| Istituto Clinico Humanitas Rozzano (MI), Lombardy | |
| Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Naples, Napoli | |
| Japan Red Cross Medical Center Shibuya-ku, | |
| Jichi Medical University Hospital Tochigi, | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Kansas University Medical Center Kansas City, Kansas | |
| Karmanos Cancer Center Wayne State University Detroit, Michigan | |
| Karmanos Cancer Center Wayne State University Detroit, Michigan | Abhinav Deol, Site 01025 |
| Karolinska University Hospital Huddinge Stockholm, | |
| Kings College Hospital London, | |
| Kinikum der Universitaeat zu Koeln Koeln, | |
| Kyushu University Hospital Fukuoka, | |
| LMU Klinikum der Universitat München, | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Local Institution - 02301 Toronto, Ontario | Site 02301 |
| Local Institution - 03151 Koeln, | Site 03151 |
| Local Institution - 03153 Ulm, | Site 03153 |
| Local Institution - 03154 München, | Site 03154 |
| Local Institution - 03501 Würzburg, | Site 03501 |
| Local Institution - 04301 Rotterdam, | Site 04301 |
| Local Institution - 05351 Gent, | Site 05351 |
| Local Institution - 07602 Ancona, | Site 07602 |
| Local Institution - 08253 Sevilla, | Site 08253 |
| Local Institution - 08451 Barcelona, | Site 08451 |
| Local Institution - 08601 Madrid, | Site 08601 |
| Local Institution - 08701 Pamplona, | Site 08701 |
| Local Institution - 09201 Pierre-Benite CEDEX, | Site 09201 |
| Local Institution - 09203 Poitiers Cedex, | Site 09203 |
| Local Institution - 09206 Montpellier CEDEX 5, | Site 09206 |
| Local Institution - 09401 Nantes Cedex 01, | Site 09401 |
| Local Institution - 10502 Manchester Withington, | Site 10502 |
| Local Institution - 12101 Wien, | Site 12101 |
| Local Institution - 13203 Osaka, | Site 13203 |
| Local Institution - 13601 Chuo-ku, Tokyo | Site 13601 |
| Local Institution - 13602 Minato-ku, Tokyo | Site 13602 |
| Local Institution - 13802 Shimotsuke, | Site 13802 |
| Local Institution - 13805 Fukuoka, | Site 13805 |
| Local Institution - 13806 Sapporo-shi, Hokkaido | Site 13806 |
| Local Institution - 15001 Stockholm, | Site 15001 |
| Lombardi Cancer Center - Georgetown University Hospital Washington, District of Columbia | |
| Loyola University Medical Center Maywood, Illinois | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | Jeremy Abramson, Site 01012 |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | Nikhil Munshi, Site 01107 |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic Rochester, Minnesota | Yi Lin, Site 01105 |
| Mayo Clinic Phoenix Phoenix, Arizona | |
| Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt Frankfurt, | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Morristown Memorial Hosp Morristown, New Jersey | |
| NYU Langone Laura and Isaac Perlmutter Cancer Center New York, New York | |
| National Cancer Center Hospital Tokyo, | |
| National Cancer Institute Putrajaya, | |
| New York Oncology Hematology P.C. Albany, New York | |
| Northside Hospital, Inc Atlanta, Georgia | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Northwestern Memorial Hospital Chicago, Illinois | Reem Karmali, Site 01014 |
| Norton Cancer Institute Louisville Oncology Louisville, Kentucky | |
| Oncology Hematology Care, Inc. Cincinnati, Ohio | |
| Oregon Health and Science University OHSU Portland, Oregon | |
| Osaka City University Hospital Osaka, | |
| Oslo Universitetssykehus Oslo, | |
| Ospedale Pediatrico Bambino Gesu Roma, | |
| Ospedali Riuniti di Ancona Ancona, | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Princess Maxima Center for Pediatric Oncology Utrecht, | |
| Providence Cancer Institute Southfield, Michigan | |
| Providence Portland Medical Center Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | Stacy Lewis, Site 01028 |
| Regional Cancer Care Associates LLC East Brunswick, New Jersey | |
| Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno Berlin, | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sam Clinical Research Center San Antonio, Texas | |
| Sam Clinical Research Center San Antonio, Texas | Julio Cesar Alvarenga Thiebaud, Site 01211 |
| Sarah Cannon Research Inst Nashville, Tennessee | |
| Seattle Children's Hospital Seattle, Washington | |
| Sidney Kimmel Comp Cancer Center at Johns Hopkins Baltimore, Maryland | |
| Sidney Kimmel Comp Cancer Center at Johns Hopkins Baltimore, Maryland | Syed Abbas Ali, Site 01017 |
| Siteman Cancer Center Saint Louis, Missouri | |
| Somers Cancer Research Building Shirley Southampton, | |
| Stanford Cancer Center Palo Alto, California | |
| Sutter Hematology and Oncology Sacramento, California | |
| Swedish Cancer Institute Seattle, Washington | |
| Texas Oncology Fort Worth, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | Houston Holmes, Site 01180 |
| Texas Oncology, P.A. - Tyler Tyler, Texas | |
| Texas Oncology, P.A. - Tyler Tyler, Texas | Habte Yimer, Site 01054 |
| The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| The Leeds Teaching Hospitals NHS Trust - St James's University Hospital Leeds, | |
| The Mayo Clinic - Jacksonville, Davis-E Jacksonville, Florida | |
| The Mayo Clinic - Jacksonville, Davis-E Jacksonville, Florida | Sikander Ailawadhi, Site 01201 |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Tokai University Hospital Isehara-Shi, Kanagawa | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyo-ku, Tokyo | |
| Tokyo Women's Medical University Hospital Tokyo, | |
| Toranomon Hospital Tokyo, | |
| UCL Cancer Institute London, | |
| UCLA Medical Centre-Santa Monica Santa Monica, California | |
| UPMC Cancer Pavillion Pittsburgh, Pennsylvania | |
| UPMC Cancer Pavillion Pittsburgh, Pennsylvania | Alison Sehgal, Site 01210 |
| UT Southwestern Medical Center Dallas, Texas | |
| UZ Gent Ghent, | |
| Universita La Sapienza Roma, | |
| Universitaetsklinikum Hamburg-Eppendorf Hamburg, | |
| Universitaetsklinikum Muenster Münster, | |
| Universitaetsklinikum Tuebingen Tübingen, Baden-Wurttemberg | |
| Universitario de Salamanca - Hospital Clinico Salamanca, | |
| Universitatsklinikum Carl Gustav Carus an der TU Dresden Dresden, | |
| Universitatsklinikum Heidelberg Heidelberg, | |
| Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II Würzburg, | |
| University Hospital Leuven Leuven, | |
| University Hospital of Ulm Ulm, | |
| University Hospitals of Cleveland Cleveland, Ohio | |
| University of Alabama Birmingham Birmingham, Alabama | |
| University of Alabama Birmingham Birmingham, Alabama | Luciano Costa, Site 01171 |
| University of Calgary Calgary, Alberta | |
| University of California San Diego Moores Cancer Center La Jolla, California | |
| University of California, San Francisco- California San Francisco, California | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Colorado Cancer Center Aurora, Colorado | |
| University of Colorado Cancer Center Aurora, Colorado | Manali Kamdar, Site 01208 |
| University of Kentucky Lexington, Kentucky | |
| University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Minnesota Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Nebraska Medical Center Omaha, Nebraska | Matthew Lunning, Site 01015 |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City, Oklahoma | |
| University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | Stephen Schuster, Site 01016 |
| University of Rochester James P. Wilmot Cancer Center Rochester, New York | |
| University of Texas- MD Anderson Houston, Texas | |
| University of Texas- MD Anderson Houston, Texas | Hun Ju Lee, Site 01013 |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | Douglas Sborov, Site 01199 |
| University of Virginia Health System Charlottesville, Virginia | |
| University of Virginia Health System Charlottesville, Virginia | Indumathy Varadarajan, Site 01065 |
| University of Wisconsin Madison, Wisconsin | |
| University of Wisconsin Madison, Wisconsin | Natalie Callander, Site 01036 |
| Vancouver General Hospital Vancouver, British Columbia | |
| Virginia Commonwealth University Richmond, Virginia | |
| Virginia Oncology Associates Norfolk, Virginia | |
| Vrije Universiteit Medisch Centrum (VUMC) Amsterdam, | |
| Weill Cornell Medicine / New York Presbyterian Hospital New York, New York | |
| Willamette Valley Cancer Institute Eugene, Oregon | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | Sagar Lonial, Site 01103 |
| Yale Cancer Center New Haven, Connecticut | |
| Yale Cancer Center New Haven, Connecticut | Iris Isufi, Site 01059 |
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 one or more of the following:
* 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
* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
* Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells.
* Patients with acute undifferentiated leukemia (AUL) are not eligible.
* For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
* T-lymphoblastic lymphoma.
* Morphologically unclassifiable lymphoma.
* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
* Patients with known Charcot-Marie-Tooth disease.
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
* Patients requiring radiation at diagnosis.
* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males. PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Show 230 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| 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, | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (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 | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| 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) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| 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 | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| 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) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| 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 | |
| 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 | |
| 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 | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | Site Public Contact - (jrhartl1@txch.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
National COVID Cohort Collaborative (N3C): A National Resource for Shared Analytics
ctrrecruit@vcu.edu
Gal, Tamas
16821
HM20019575
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia |
Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
Dorothy Sung - dsung@nybc.org
McCarty, John, M.
NCT01656603
HM14815
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Inclusion Criteria:
• Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
• Patients: Patients of any age and either gender
• Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Exclusion Criteria:
• Patients who are receiving licensed cord blood products (only)
• Patients who are receiving unlicensed cord blood products from other banks (only)
• Patients who are transplanted at non-US transplant centers
• Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
BIOLOGICAL: unlicensed CBU
Infusion Reactions
cord blood, transplantation, stem cells, adverse event
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Show 71 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania Medical Center Philadelphia, Pennsylvania | |
| Akron Children's Hospital Akron, Ohio | |
| Alfred I. DuPont Hospital for Children Wilmington, Delaware | |
| All Children's Hospital, John Hopkins Medicine St. Petersburg, Florida | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Arthur G. James Cancer Hospital Columbus, Ohio | |
| Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center St Louis, Missouri | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Children's Healthcare of Atlanta Atlanta, Georgia | |
| Children's Hopsital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | |
| Children's Medical Center of Dallas Dallas, Texas | |
| Children's National Medical Center Washington D.C., District of Columbia | |
| Children's Of Alabama Birmingham, Alabama | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| City of Hope Duarte, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Cohen Children's Medical Center of NY New Hyde Park, New York | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Dana Farber Cancer Instistute Boston, Massachusetts | |
| Doernbecher Children's Hospital / Oregon Health & Science University Portland, Oregon | |
| Florida Hospital, Florida Center for Cellular Therapy Orlando, Florida | |
| Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance Seattle, Washington | |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | |
| Henry Ford Health System Detroit, Michigan | |
| Indiana University Indianapolis, Indiana | |
| James Graham Brown Cancer Center Louisville, Kentucky | |
| Loyola University Medical Center Maywood, Illinois | |
| Massachusetts General Hospital Lexington, Massachusetts | |
| Mayo Clinic Arizona Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | |
| Memorial Sloan-Kettering Cancer Center New York, New York | |
| Methodist Hospital / Texas Transplant Institute San Antonio, Texas | |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Hospital New York, New York | |
| National Institutes of Health Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Nemour's Children's Clinic and Hospital Jacksonville, Florida | |
| New York Presbyterian Hospital WCMC New York, New York | |
| Northside Hosptal Atlanta, Georgia | |
| Northwell Health - North Shore University Hospital Manhasset, New York | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Penn State Health / Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Presbyterian / St. Luke's Medical Center Denver, Colorado | |
| Rady Children's Hospital San Diego, California | |
| Seidman Cancer Center Cleveland, Ohio | |
| Southwestern Regional Medical Center Tulsa, Oklahoma | |
| St Jude Children's Research Center Memphis, Tennessee | |
| St. Louis University Hospital St Louis, Missouri | |
| Stanford Health Care San Jose, California | |
| Stephenson Oklahoma Cancer Center Oklahoma City, Oklahoma | |
| Texas Children's Cancer Center Houston, Texas | |
| The Children's Hospital of Colorado Aurora, Colorado | |
| The Nebraska Medical Center Omaha, Nebraska | |
| UCLA Healthcare Los Angeles, California | |
| UCSD Moores Cancer Center La Jolla, California | |
| University of Arizona Medical Center Tucson, Arizona | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Miami Health System Sylvester Comprehensive Cancer Center Miami, Florida | |
| University of Miami/Jackson Memorial Hospital Miami, Florida | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Rochester Medical Center Rochester, New York | |
| University of Virginia Charlottesville, Virginia | |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| West Virginia University Hospitals Inc Morgantown, West Virginia |
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs (NEAR4KIDs)
Hayley Buffman, MPH - buffmanh@chop.edu
Bain, Jesse
NCT02493478
HM20000941
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Inclusion Criteria:
* Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency tracheostomy and/or cricothyrotomy
* Failed extubation attempts or unplanned extubations that require re-intubation will be considered a new primary intubation.
Exclusion Criteria:
* Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites. Failed or Difficult Intubation, Sequela, Intubation, Difficult, Intubation Complication
Intubation, Advanced airway intervention, Intensive care unit
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Show 87 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aichi Children's Health and Medical Center Ōbu, | |
| Akron Children's Hospital Akron, Ohio | |
| Albany Medical College Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Simon Parsons, MD - (simon.Parsons@albertahealthservices.ca) |
| American Family Children's Hospital - University of Wisconsin Madison, Wisconsin | |
| Arkansas Children's Hospital Little Rock, Arkansas | Office of Research and Sponsored Programs - (rcsanders@uams.edu) |
| Aster Hospitals - India Bengaluru, Karnataka | |
| Bambino Gesu Roma, | |
| Baylor - Christus Children's - Main Hospital Irving, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baylor - Christus Children's - Stone Oak San Antonio, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baylor - Christus Children's - Westover Hills San Antonio, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | |
| Beacon Children's Hospital South Bend, Indiana | |
| Boston Children's Hospital Boston, Massachusetts | |
| British Columbia Children's Hospital Vancouver, British Columbia | Gordon Krahn, MD - (gkrahn@cw.bc.ca) |
| CHU Sainte-Justine Montreal, Quebec | Guillaume Emeriaud, MD - (guillaume.emeriaud@umontreal.ca) |
| CHU Sainte-Justine Montreal, Quebec | |
| Cardiff & Vale University Health Board Cardiff, Wales | |
| Children's Hospital - Penn State Hershey Hershey, Pennsylvania | Ashley Derbyshire, MD - (aderbyshire@hmc.psu.edu) |
| Children's Hospital and Medical Center Omaha, Nebraska | |
| Children's Hospital of Atlanta - Scottish Rite Atlanta, Georgia | |
| Children's Hospital of Central California Madera, California | |
| Children's Hospital of Georgia Augusta, Georgia | |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | |
| Children's of Alabama at Birmingham Birmingham, Alabama | University of Alabama at Birmingham Institutional Review Board - (irb@uab.edu) |
| Cincinnati Hospital Medical Center Cincinnati, Ohio | |
| Cleveland Clinic Childrens Hospital Cleveland, Ohio | |
| Cohen Children's Medical Center Queens, New York | |
| Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire | Sholeen Nett, MD - (sholeen.t.nett@hitchcock.org) |
| Dell Children's Medical Center - Ascension Austin, Texas | |
| Duke Children's Hospital Durham, North Carolina | Kyle Rehder, MD - (kyle.rehder@duke.edu) |
| Emory University Atlanta, Georgia | Pradip Kamat, MD - (pradip.kamat@choa.org) |
| Foothills Medical Centre Calgary, | |
| Gillette Children's Specialty Health Saint Paul, Minnesota | |
| Hasbro Children's Hospital Providence, Rhode Island | Lee Polikoff, MD - (lee.polikoff@lifespan.org) |
| Hiroshima University Hiroshima, | |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Hyogo Prefectural Kobe Children's Hospital Kobe, Hyōgo | |
| Jichi Medical University Hospital Tochigi, | |
| Johns Hopkins Medicine Baltimore, Maryland | Office of Human Subjects Research IRB - (jhmeirb@jhmi.edu) |
| KK Women's & Children's Hospital, Singapore Singapore, | Jan H Lee, MD - (lee.jan.hau@kkh.com.sg) |
| KK Women's and Children's Hospital Singapore, | |
| Kentucky Children's Hospital Lexington, Kentucky | Ashwin Krishna, MD - (ashwin.krishna@uky.edu) |
| Le Bonheur Children's Hospital Memphis, Tennessee | |
| Maria Fareri Children's Hospital (West Chester Medical) Valhalla, New York | Simon Li, MD - (lis@WCMC.com) |
| Medical City Children's Hospital Dallas, Texas | Kris Bysani, MD - (KrisBysani@gmail.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of Vienna (Medizinische Universität Wien) Vienna, | |
| Miami Children's Hospital Miami, Florida | |
| Morristown Medical Center Morristown, New Jersey | Atlantic Health System - (anita.richards@atlantichealth.org) |
| National Center for Child Health and Development Tokyo, | |
| Nationwide Children's Hospital Columbus, Ohio | Anthony Lee, MD - (Anthony.Lee@nationwidechildrens.org) |
| Nemours Children's Health, Delaware Wilmington, Delaware | |
| New York Presbyterian Hospital Weill Cornell Medical College New York, New York | |
| Northwestern Medicine Prentice Women's Hospital Chicago, Illinois | |
| Norton Children's Hospital - University of Louisville Louisville, Kentucky | |
| Oishei Children's Hospital Buffalo, New York | Ryan Breuer, MD - (ryankbreuer@gmail.com) |
| Oregon Health and Science University Portland, Oregon | Paula Vanderford, MD - (vanderfo@ohsu.edu) |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | Kathleen May - (khay@hmc.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | PCH IRB - (swalker@phoenixchildrens.com) |
| Rainbow Children's Hospital Bangalore, | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Royal Brisbane and Women's Hospital Herston, Queensland | |
| Saitama Children's Medical Center Chuo-ku, Saitama | |
| Seattle Children's Hospital Seattle, Washington | Alisyn Franetich - (alisyn.franetich@seattlechildrens.org) |
| Starship Children's Hospital Grafton, Auckland | |
| Stony Brook Children's Hospital Stony Brook, New York | |
| The Children's Hospital at Montefiore The Bronx, New York | |
| The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Children's Hospital of Philadelphia IRB Office - (irboffice@chop.edu) |
| The Royal Children's Hospital Melbourne Parkville, | |
| The University of Manitoba Winnipeg, | |
| The University of Vermont Children's Hospital Burlington, Vermont | Iris Toedt-Pingel, MD - (iris.toedt-pingel@uvmhealth.org) |
| Tokyo Metropolitan Tokyo, | Takanari Ikeyama, MD - (taqnary@gmail.com) |
| UVA Children's Hospital Charlottesville, Virginia | Michelle Adu-Darko, MD - (maa7j@hscmail.mcc.virginia.edu) |
| University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital Lübeck, | |
| University of Colorado Hospital Aurora, Colorado | John Heldens - (john.heldens@ucdenver.edu) |
| University of Maryland Towson, Maryland | |
| University of Rochester at Golisano Children's Hospital Rochester, New York | |
| University of Washington Medical Center Seattle, Washington | Alisyn Franetich - (alisyn.franetich@seattlechildrens.org) |
| University of Wisconsin - American Family Children's Hospital Shorewood Hills, Wisconsin | The University of Wisconsin IRB - (pjpeebles@wisc.edu) |
| University of Wisconsin - UnityPoint Meriter Madison, Wisconsin | Liz Michaels - (liz.michaels@unitypoint.org) |
| WakeMed Raleigh, North Carolina | Elizabeth Woodard, RN, PhD - (WakeMed_IRB_Office@wakemed.org) |
| WakeMed Health & Hospitals Raleigh, North Carolina | |
| Yale New Haven Children's Hospital New Haven, Connecticut | Stephen Latham, JD, PhD - (human.subjects@yale.edu) |
| Yale-New Haven Children's Hospital New Haven, Connecticut | John Giuliano, MD - (john.giuliano@yale.edu) |
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT03126916
HM20015351
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Inclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \>= 365 days and =\< 30 years of age at diagnosis
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:
* Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
* MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
* Age \> 547 days regardless of biologic features
* Patients with INRG stage MS disease with MYCN amplification
* Patients with INRG stage L2 disease with MYCN amplification
* Patients \> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M
* Patients \>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows:
* 1 to \< 2 years: male = 0.6; female = 0.6
* 2 to \< 6 years: male = 0.8; female = 0.8
* 6 to \< 10 years: male = 1; female = 1
* 10 to \< 13 years: male = 1.2; female = 1.2
* 13 to \< 16 years: male = 1.5; female = 1.4
* \>= 16 years: male = 1.7; female = 1.4
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \> 50% by echocardiogram or radionuclide angiogram
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be \> 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Exclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Busulfan, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dexrazoxane Hydrochloride, BIOLOGICAL: Dinutuximab, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography Test, DRUG: Etoposide Phosphate, RADIATION: External Beam Radiation Therapy, RADIATION: Iobenguane I-123, RADIATION: Iobenguane I-131, DRUG: Isotretinoin, DRUG: Lorlatinib, PROCEDURE: Magnetic Resonance Imaging, DRUG: Melphalan Hydrochloride, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Sargramostim, PROCEDURE: Therapeutic Conventional Surgery, DRUG: Thiotepa, DRUG: Topotecan Hydrochloride, DRUG: Vincristine Sulfate
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
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Show 162 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (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 | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | |
| 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 | |
| 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 | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| 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) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| 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) |
| Rady Children's Hospital - San Diego San Diego, California | |
| 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 - (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 | |
| 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) |
| 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) |
| 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 | Site Public Contact - (research@sncrf.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| 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 California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | |
| 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) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (STOP PIV)
Courtney Alcaraz - cburke@ansunbiopharma.com
Miller, Kristin, B.
NCT03808922
HM20016591
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Inclusion Criteria:
• At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
• Immunocompromised, as defined by one or more of the following: * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past * Received a solid organ transplant at any time in the past * Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past * Has an immunodeficiency due to congenital abnormality (only applicable to subjects age \< 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
• Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
• If female, subject must meet one of the following conditions: * Not be of childbearing potential or * Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol
• Provides signed informed consent prior to the initiation of any screening or study-specific procedures For COVID-19 sub study:
• Be ≥18 years of age
• Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
• Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
• Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
• Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
• Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion Criteria:
• Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
• Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
• Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• Subjects taking any other investigational drug used to treat pulmonary infection.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
• Subjects with known hypersensitivity to DAS181 and/or any of its components
• Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria: * Has evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Requires vasopressors to maintain blood pressure For COVID-19 sub study:
• Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
• Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
• Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
• Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
• Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria: * Have evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Require vasopressors to maintain blood pressure
• Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
DRUG: DAS181, DRUG: Placebo, DRUG: DAS181 COVID-19, DRUG: DAS181 OL
Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19
Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun
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Show 67 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Asan Medical Center Seoul, Seoul-teukbyeolsi [seoul] | |
| Baylor College of Medicine Houston, Texas | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Children's Hospital Colorado Aurora, Colorado | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| City of Hope cancer Center Newnan, Georgia | |
| Cook Children's Forth Worth, Texas | |
| Duke University Durham, North Carolina | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Medical College Pulmonary Clinic Milwaukee, Wisconsin | |
| Hopital Henri Mondor Créteil, | |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Hospital Houston, Texas | |
| Kent Hospital Warwick, Rhode Island | |
| Louisiana State University Shreveport, Louisiana | |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Houston, Texas | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| National Cheng Kung University Hospital Tainan, | |
| National Taiwan University Hospital Taipei, | |
| Novant Health Winston-Salem, North Carolina | |
| Oregon Health & Science University Portland, Oregon | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Prince of Wales Hospital Hong Kong, Hong Kong SAR | |
| Rigshospitalet Copenhagen, Capital Region | |
| Royal Melbourne Hospital Parkville, Victoria | |
| Samsung Medical Center Seoul, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Shanghai Pulmonary Hospital Shanghai, | |
| Shulan (Hangzhou) Hospital co., LTD Hangzhou, Zhejiang | |
| St. Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Sylvester Comprehensive Cancer Center, University of Miami Health System Miami, Florida | |
| Texas Health Forth Worth, Texas | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The Cleveland Clinic Foundation Cleveland, Ohio | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The Johns Hopkins Hospital Baltimore, Maryland | |
| The Lindner Center- The Christ Hospital Cincinnati, Ohio | |
| The Wesley Hospital Auchenflower, Queensland | |
| Therapeutic Concepts Houston, Texas | |
| UCLA Los Angeles, California | |
| UT Southwestern Medical Center Dallas, Texas | |
| University of California Davis Health System Sacramento, California | |
| University of California San Diego Medical Center San Diego, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Iowa Health Care Waukee, Iowa | |
| University of Kansas Medical Center Kansas City, Kansas | |
| University of Maryland Towson, Maryland | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Pittsburgh Medical Center Health System Pittsburgh, Pennsylvania | |
| Universtiy of Michigan Ann Arbor, Michigan | |
| VCU Health System Richmond, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Washington University St Louis, Missouri | |
| Weill Cornell Medical College New York, New York | |
| West China Hospital Chengdu, Sichuan | |
| Westmead Hospital Northmead, New South Wales |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Austin, Frances
NCT03067181
HM20015718
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Inclusion Criteria:
* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\])
* Standard risk 1: Patients must be \< 11 years of age at enrollment
* Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).
* Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:
* Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided
* Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \[AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently
* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \[\< 3 mm\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages
* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11
* Standard risk 2 (SR2)
* Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25
* Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25
* Notes:
* IGCCC criteria only apply to SR2 patients with a testicular primary tumor
* Use post-op tumor marker levels to determine IGCCC risk group
* Pure seminoma patients are not eligible for the standard risk arms of the study
* For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
* Adequate renal function defined as:
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL)
* 1 month to \< 6 months male: 0.4 female: 0.4
* 6 months to \< 1 year male: 0.5 female: 0.5
* 1 to \< 2 years male: 0.6 female: 0.6
* 2 to \< 6 years male: 0.8 female: 0.8
* 6 to \< 10 years male: 1 female: 1
* 10 to \< 13 years male: 1.2 female: 1.2
* 13 to \< 16 years: male: 1.5 female: 1.4
* \>= 16 years male: 1.7 female: 1.4
* Total bilirubin =\< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
* Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)
* Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
* Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3 (within 7 days prior to enrollment) AND
* Platelet count \>= 75,000/mm\^3 (within 7 days prior to enrollment)
* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
* \>= 11 and \< 25 years old at enrollment
* Able to fluently speak and read English
* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
* Followed for cancer or survivorship care at one of the following institutions:
* Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
* Dana Farber/Harvard Cancer Center
* Hospital for Sick Children
* Children's Hospital of Eastern Ontario
* Oregon Health and Science University
* Seattle Children's Hospital
* Yale University
Exclusion Criteria:
* Patients with any diagnoses not listed including:
* Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
* Pure ovarian or extragonadal dysgerminoma/seminoma
* Pure mature teratoma
* Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL
* "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or
* Primary central nervous system (CNS) germ cell tumor
* Germ cell tumor with somatic malignant transformation
* Spermatocytic seminoma
* Patients must have had no prior systemic therapy for the current cancer diagnosis
* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial)
* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
* 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; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Etoposide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Pulmonary Function Test, OTHER: Questionnaire Administration
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
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Study Locations
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| Location | Contacts |
|---|---|
| Addenbrookes Hospital-Medical School Cambridge, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| 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 | |
| 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) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Ann M Wierman MD LTD Las Vegas, Nevada | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | |
| 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) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beatson Oncology Center Glasgow, Scotland | |
| Bethesda North Hospital Cincinnati, Ohio | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Camden Clark Medical Center Parkersburg, West Virginia | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Care Specialists - Reno Reno, Nevada | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | |
| Cancer Center at Saint Joseph's Phoenix, Arizona | |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Therapy and Integrative Medicine Las Vegas, Nevada | |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | |
| Cancer and Blood Specialists-Shadow Las Vegas, Nevada | |
| Cancer and Blood Specialists-Tenaya Las Vegas, Nevada | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle Cancer Center Urbana, Illinois | |
| Carle Physician Group-Effingham Effingham, Illinois | |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | |
| Carle at The Riverfront Danville, Illinois | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| 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) |
| Chancellor Center for Oncology Newburgh, Indiana | |
| Chiba University Chiba-sgi, Chiba | Site Public Contact - (helpdesk@childrensoncologygroup.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 Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| 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 Children's Hospital Dayton, Ohio | |
| Deaconess Clinic Downtown Evansville, Indiana | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Desert West Surgery Las Vegas, Nevada | |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Essentia Health Cancer Center Duluth, Minnesota | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred and Pamela Buffett Cancer Center - Kearney Kearney, Nebraska | |
| Freeman Hospital Newcastle upon Tyne, HIGH Heaton | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| 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) |
| Glens Falls Hospital Glens Falls, New York | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Greater Regional Medical Center Creston, Iowa | |
| Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin | John R. Hill - (Christy.Gilchrist@hshs.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| HSHS Saint Nicholas Hospital Sheboygan, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| Hematology and Oncology Consultants PC Omaha, Nebraska | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Highline Medical Center-Main Campus Burien, Washington | |
| Hiroshima University Hospital Hiroshima, | |
| Hokkaido University Hospital Sapporo, Hokkaido | Site Public Contact - (hassi@med.hokudai.ac.jp) |
| Holy Family Memorial Hospital Manitowoc, Wisconsin | |
| 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 | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| Hyogo College of Medicine Nishinomiya, Hyogo, | |
| Hyogo Prefectural Kobe Children's Hospital Kobe, Hyōgo | Site Public Contact - (info_kch@hp.pref.hyogo.jp) |
| IU Health North Hospital Carmel, Indiana | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| 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) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jefferson Abington Hospital Abington, Pennsylvania | |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| John Radcliffe Hospital Oxford, | Site Public Contact - (helpdesk@childrensoncologygroup.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) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| 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 Medical Center - Santa Clara Santa Clara, California | |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | |
| Kaiser Permanente Washington Seattle, Washington | |
| 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-Capitol Hill Medical Center Washington D.C., District of Columbia | |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kanagawa Children's Medical Center Yokohama, Kanagawa | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Keio University Shinjuku-ku, Tokyo | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kokuritsu Seiiku Medical Research Center Hospital Tokyo, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Kyoto Perfectural University of Medicine Kyoto, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Kyushu Univeristy Higashiku, Fukuoka | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lake Huron Medical Center Port Huron, Michigan | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| 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) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Leeds General Infirmary Leeds, West Yorkshire | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Longmont United Hospital Longmont, Colorado | |
| Los Angeles General Medical Center Los Angeles, 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) |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| 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) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Matthews Radiation Oncology Center Matthews, North Carolina | |
| 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 Center of the Rockies Loveland, Colorado | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial GYN Plus Ooltewah, Tennessee | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital Chattanooga, Tennessee | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital Chattanooga, Tennessee | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| 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 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 Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy San Juan Medical Center Carmichael, California | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Midlands Community Hospital Papillion, Nebraska | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Health Center West Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mountain Blue Cancer Care Center Golden, Colorado | |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane, Washington | |
| MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane, Washington | |
| MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley, Washington | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| National Cancer Center Hospital Tokyo, | Site Public Contact - (www-admin@ncc.go.jp) |
| 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 | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| 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 | |
| Niigata Cancer Centre Niigata, Chuo-ku | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| North Grove Medical Park Spartanburg, South Carolina | |
| North Shore Medical Center Skokie, Illinois | |
| 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 | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Cancer Institute - Huntersville Huntersville, North Carolina | |
| Novant Health Cancer Institute - Matthews Matthews, North Carolina | |
| Novant Health Cancer Institute - Mooresville Mooresville, North Carolina | |
| Novant Health Cancer Institute - Rowan Salisbury, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oncology Specialists of Charlotte Charlotte, North Carolina | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Osaka City General Hospital Osaka, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | |
| Pacific Gynecology Specialists Seattle, Washington | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Parkland Health Center-Bonne Terre Bonne Terre, Missouri | |
| Parkland Memorial Hospital Dallas, Texas | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| PeaceHealth Southwest Medical Center Vancouver, Washington | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Cancer Institute - Butternut Greenville, 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) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.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 Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Shelton Shelton, Washington | |
| Providence Regional Cancer System-Yelm Yelm, Washington | |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Pulmonary Medicine Center of Chattanooga-Hixson Hixson, Tennessee | |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Rocky Mountain Cancer Centers - Pueblo Pueblo, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | |
| Rocky Mountain Cancer Centers-Parker Parker, Colorado | |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| 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) |
| Rowan Regional Medical Center Salisbury, North Carolina | |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Royal Hospital for Children Glasgow, Scotland | Site Public Contact - (Randdsystems.PF1@ggc.scot.nhs.uk) |
| Royal Hospital for Children and Young People Edinburgh, | |
| Royal Manchester Children Hospital Manchester, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Royal Victoria Infirmary Newcastle upon Tyne, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | |
| Rush-Copley Healthcare Center Yorkville, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Bartholomew's Hospital London, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
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| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint James's University Hospital West Yorkshire, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
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| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| 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 Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Rita's Medical Center Lima, Ohio | Site Public Contact - (Jeffh@columbusccop.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 Marinette Marinette, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Saitama Children's Medical Center Chuo-ku, Saitama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saitama Medical University International Medical Center Saitama, | |
| 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) |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sheffield Children's Hospital Sheffield, | Site Public Contact - (r.innovation@nhs.net) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
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| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Southern Oncology Specialists-Charlotte Charlotte, North Carolina | |
| Southern Oncology Specialists-Huntersville Huntersville, North Carolina | |
| Southwest Illinois Health Services LLP Swansea, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Spartanburg Medical Center - Mary Black Campus Spartanburg, South Carolina | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | |
| 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 | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| 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) |
| Sutter Medical Center Sacramento Sacramento, California | |
| 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-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| 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) |
| Tata Memorial Hospital Mumbai, Maharashtra | Site Public Contact - (ctsucontact@westat.com) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| Texas Tech University Health Sciences Center-El Paso El Paso, Texas | |
| Texas Tech University Health Sciences Center-Lubbock Lubbock, Texas | |
| The Carle Foundation Hospital Urbana, Illinois | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| 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 | |
| Tohoku University School of Medicine Sendai, Aoba-ku | Site Public Contact - (med-som@bureau.tohoku.ac.jp) |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tufts Children's Hospital Boston, Massachusetts | |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
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| 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) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
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| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Center Bridgeport, West Virginia | |
| University Cancer Center Las Vegas, Nevada | |
| University College London Hospitals NHS Trust - Foley Street London, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Hospital San Antonio, Texas | Site Public Contact - (evelyn.swenson-britt@uhs-sa.com) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | |
| 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 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 Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of 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 Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
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| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Tsukuba Hospital Tsukuba, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Vermont Medical Center Burlington, Vermont | |
| 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 - Johnson Creek Johnson Creek, Wisconsin | |
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| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
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| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Radiation Oncology Peru, Illinois | |
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| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
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| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
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| Western General Hospital Edinburgh, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
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| Weston Park Hospital Sheffield, | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Woodland Memorial Hospital Woodland, California | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children (FSGS pediatric)
Ayaka Kitamura - Ayaka.Kitamura1@kaneka.co.jp
Lo, Megan
NCT02235857
HM20012146
Show full eligibility criteria
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Inclusion Criteria:
* A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following:
* Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);
* Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);
* Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.
or
• Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
Exclusion Criteria:
* General Exclusion Criteria
* Patient is greater than 21 years of age
* Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)
* Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.)
* Unable or unwilling to comply with the follow-up schedule
* Simultaneously participating in another investigational drug or device study
* Body weight \< 15 kg (33.1 lbs)
* Medical Exclusion Criteria
* Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
* Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure
* Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
* Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
* Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
* Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension
* Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease
* Functional thyroid disease or liver abnormalities
* Unresolved systemic or local infection that could affect the clinical study outcomes DEVICE: LIPOSORBER® LA-15 System
Focal Segmental Glomerulosclerosis
pediatric, renal transplantation, recurrence, drug-resistant
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Show 12 locations
Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | Rupesh Raina, MD - (RRaina@chmca.org) Ann Pokelsek, BSN, RN, - (apokelsek@akronchildrens.org) |
| Cedars Sinai Medical Center Los Angeles, California | Ananth S Karumanchi - (SAnanth.Karumanchi@csmc.edu) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | |
| Loma Linda University Children's Hospital Loma Linda, California | |
| Medical University of South Carolina Children's Hospital Charleston, South Carolina | Katherine E Twombley, MD - (twombley@musc.edu) |
| Nemours Children's Health Pensacola, Florida | |
| Nemours/A.I. duPont Hospital for Children Wilmington, Delaware | Joshua Zaritsky, MD PhD - (joshua.zaritsky@nemours.org) |
| St. Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| University of Minnesota Minneapolis, Minnesota | Michelle Rheault, MD - (rheau002@umn.edu) |
| University of North Carolina Chapel Hill, North Carolina | Anne Froment - (anne_froment@med.unc.edu) |
| Weill Cornell Medical Center / NewYork-Presbyterian New York, New York | Eduardo M Perelstein, MD - (emperels@med.cornell.edu) |
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Madu, Mary, E - memadu@vcu.edu
Wang, Zhihong, Joanne
NCT04166409
HM20020781
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Inclusion Criteria:
* Patients must be \>= 2 years and =\< 21 years at the time of enrollment
* Patients must have a body surface area (BSA) of \>= 0.5 m\^2 at enrollment
* Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) Childhood Cancer Data Initiative (CCDI)-MCI, or accepted Clinical Laboratory Improvement Act (CLIA)-certified test and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation.
* Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible
* Patients must have two-dimensional measurable tumor \>= 1 cm\^2 to be eligible
* Patients with ependymoma are not eligible
* Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization \[WHO\] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
* Patients with metastatic disease or multiple independent primary LGG are eligible
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (performed within 7 days prior to enrollment):
* Age: Maximum Serum Creatinine (mg/dL)
* 2 to \< 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
* 6 to \< 10 years: 1 mg/dL (male); 1 mg/dL (female)
* 10 to \< 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
* 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
* \>= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect \[unconjugated\] bilirubin levels as long as their direct \[conjugated\] bilirubin is \< 3.1 mg/dL)
* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
* Albumin \>= 2 g/dL (performed within 7 days prior to enrollment)
* Left ventricular ejection fraction (LVEF) \>= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)
* Corrected QT (QTc) interval =\< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)
* Absolute neutrophil count \>= 1,000/uL (unsupported) (performed within 7 days prior to enrollment)
* Platelets \>= 100,000/uL (unsupported) (performed within 7 days prior to enrollment)
* Hemoglobin \>= 8 g/dL (may be supported) (performed within 7 days prior to enrollment)
* Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
* Patients 2-17 years of age must have a blood pressure that is =\< 95th percentile for age, height, and sex at the time of enrollment (with or without the use of anti-hypertensive medications)
* Patients \>= 18 years of age must have a blood pressure =\< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)
* Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension
* All patients must have ophthalmology toxicity assessments performed within 8 weeks prior to enrollment
* For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 8 weeks prior to enrollment
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients must have the ability to swallow whole capsules
* 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
* All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)
* All patients have been consented and enrolled on APEC14B1 (NCT02402244) Part A for Pre-Enrollment Eligibility Screening for ACNS1833
Exclusion Criteria:
* Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention (with the exclusion of laser interstitial thermal therapy \[LITT\]) is permitted
* Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
* Patients with diffuse intrinsic pontine tumors as seen on MRI (\> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology
* Patients may not be receiving any other investigational agents
* Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
* Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
* Female patients who are pregnant are not eligible 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 are not eligible
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 1 week after stopping study therapy are not eligible.
* Note: Women study participants of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of selumetinib. Men study participants with sexual partners who are pregnant or who are of child-bearing potential must use acceptable contraception during the study and for 1 week (7 days) after the last dose of study agent. Acceptable contraception includes implants, injectables, or oral contraceptives (all combined with barrier methods), some intrauterine devices (IUDs), vasectomy or abstinence
* Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented
* Symptomatic heart failure
* New York Health Association (NYHA) class II-IV prior or current cardiomyopathy
* Severe valvular heart disease
* History of atrial fibrillation
* Current or past history of central serous retinopathy
* Current or past history of retinal vein occlusion or retinal detachment
* Patients with uncontrolled glaucoma
* If checking pressure is clinically indicated, patients with intraocular pressure (IOP) \> 22 mmHg or ULN adjusted by age are not eligible
* Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
* Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.
* Note: Patients must have healed from any prior surgery
* Patients who have an uncontrolled infection are not eligible PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, OTHER: Questionnaire Administration, DRUG: Selumetinib Sulfate, DRUG: Vincristine Sulfate
Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma, WHO Grade 1 Glioma, WHO Grade 2 Glioma
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Show 132 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.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 | |
| 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 | |
| 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) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital 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 of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| 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) |
| 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, | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-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) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| 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 | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Morristown Medical Center Morristown, New Jersey | |
| 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) |
| OSF Children's Hospital of Illinois Peoria, Illinois | Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| 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) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| 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 Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| 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 Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of 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 Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of 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 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) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
Eisai Medical Information - esi_medinfo@eisai.com
NCT04015141
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Inclusion Criteria:
* Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth.
* Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
* Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
* Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging \[MRI\] scan or computed tomography \[CT\] or ultrasound \[for less than 1 year old\]).
* Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than \[\<\] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
Exclusion Criteria:
* Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
* Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
* Have an unstable psychiatric diagnosis that may confound participant's ability to participate in the study or that may prevent completion of the protocol specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before screening visit 1, current psychotic disorder, acute mania).
* Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
* Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
* Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
* Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed.
* A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study).
* Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
* Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening). DRUG: Perampanel Oral Suspension, DRUG: Perampanel Tablet
Pediatric Epileptic Syndrome, Partial-onset Seizures
Partial-onset seizures, Pediatric epileptic syndrome, Epilepsy, Childhood epilepsy, Epilepsy in children, Refractory seizures, Inadequately controlled seizures, E2007, Fycompa, Perampanel
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Show 49 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aarhus Universitetshospital Aarhus N, Central Jutland | |
| CHRU Rennes Rennes, | |
| CHUS � H. Clinico U. de Santiago Santiago de Compostela, | |
| Center For Neurosciences Tucson, Arizona | |
| Centre Hospitalier Universitaire de Toulouse Toulouse, | |
| Centre Neurologique William Lennox Ottignies, Brabant Wallon | |
| Centro Medico Teknon � Grupo Quironsalud Barcelona, | |
| Child Neurology Consultants of Austin Austin, Texas | |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Richmond at VCU - CHoR-PIN Richmond, Virginia | |
| Children's Specialty Group Norfolk, Virginia | |
| Childrens Hospital Colorado Aurora, Colorado | |
| Cliniques Universitaires Saint-Luc Brussels, | |
| Columbia University Medical Center New York, New York | |
| Complejo Hospitalario de Navarra Pamplona, Navarre | |
| David Geffen School of Medicine at UCLA Los Angeles, California | |
| Dayton Children's Hospital Dayton, Ohio | |
| Doernbecher Children's Hospital Portland, Oregon | |
| Dr. von Haunersches Kinderspital Munich, | |
| Fakultni Nemocnice Ostrava Ostrava - Poruba, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Plzen Pilsen, | |
| Hopital Necker Paris, | |
| Hopitaux de La Timone Marseille, Bouches-du-Rhône | |
| Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676 Paris, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital General Universitario Gregorio Mara�on Madrid, | |
| Hospital Universitario Virgen del Rocio - PPDS Seville, | |
| H�pital Erasme Anderlecht, | |
| H�pital Pellegrin-Enfants Bordeaux, | |
| H�pital Universitaire des Enfants Reine Fabiola Brussels, Brussels Capital | |
| Kleinwachau S�chsisches Epilepsiezentrum Radeberg Gemeinn�tzige Gmbh Radeberg, | |
| Meridian Clinical Research-(Savannah Georgia) Savannah, Georgia | |
| Nemours Foundation Alfred Dupont Children's Hospital Wilmington, Delaware | |
| Nicklaus Children's Hospital Miami, Florida | |
| Northeast Regional Epilepsy Group Hackensack, New Jersey | |
| PANDA Neurology Atlanta, Georgia | |
| Pediatric Epilepsy and Neurology Specialists Tampa, Florida | |
| Pediatric Neurology PA Orlando, Florida | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Regionshospitalet Randers Randers, | |
| Road Runner Research Ltd San Antonio, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| UZ Brussel Brussels, Brussels Capital | |
| UZ Gent Ghent, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| Universit�tsklinikum Freiburg Freiburg im Breisgau, | |
| Universit�tsklinikum Jena Jena, | |
| Wake Forest Baptist Medical Center - PPDS Winston-Salem, North Carolina |
Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) (MOVE FSHD)
Michaela Walker, MPH - mwalker20@kumc.edu
Johnson, Nicholas, E
NCT04635891
HM20021534
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Inclusion Criteria:
* Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring.
Exclusion Criteria:
* Unwilling or unable to provide informed consent.
* Any other medical condition which in the opinion of the investigator would interfere with study participation. FSHD
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Study Locations
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| Location | Contacts |
|---|---|
| Austin Neuromuscular Center Austin, Texas | Hina Patel - (hina@austinneuromuscle.com) Emil Hussain - (emil@austinneuromuscle.com) |
| David Geffen School of Medicine at UCLA Los Angeles, California | Dova Levin - (dvlevin@mednet.ucla.edu) Merve Kaleli - (MKaleli@mednet.ucla.edu) |
| Duke University - Lenox Baker Children's Hospital Durham, North Carolina | Randy Smith, MPH - (randy.s.smith@duke.edu) Stepanie Thera - (stephanie.thera@duke.edu) |
| Kennedy Krieger Institute Baltimore, Maryland | Mary Yep - (Yep@kennedykrieger.org) Geni Bibat - (bibat@kennedykrieger.org) |
| Neuromuscular Disorders Program at Stanford University School of Medicine Stanford, California | - (NeuromuscularResearch@stanford.edu) |
| Ottawa Hospital Research Institute Ottawa, Ontario | Jessica Belanger - (jemacgregor@ohri.ca) Kathryn Beaudry - (kabeaudry@ohri.ca) |
| Sheffield Teaching Hospital Sheffield, South Yorkshire | Jon Street - (j.street1@nhs.net) - (sth.neuromuscularresearch@nhs.net) |
| The Ohio State University Medical Center Columbus, Ohio | Alison Arter - (Alison.Arter@osumc.edu) Marco Tellez - (Marco.Tellez@osumc.edu) |
| Univeristy of Florida Gainesville Gainesville, Florida | Julie Segura - (Julie.segura@neurology.ufl.edu) |
| Univeristy of Kansas Medical Center Kansas City, Kansas | Andrea Klempnauer - (atenney@kumc.edu) Rebecca Clay - (rclay@kumc.edu) |
| Univeristy of Texas Southwestern Medical Center Dallas, Texas | Tyler Arrington - (Tyler.Arrington@UTSouthwestern.edu) Steve Hopkins - (Steve.Hopkins@UTSouthwestern.edu) |
| University of Calgary Calgary, Alberta | Janet Petrillo - (japetril@ucalgary.ca) Carissa Wong - (carissa.wong@ucalgary.ca) |
| University of Colorado Anschutz Medical Campus Aurora, Colorado | - (neurologyresearchpartners@cuanschutz.edu) |
| University of Iowa Iowa City, Iowa | Catherine Buescher, MS, BHS - (catherine-buescher@uiowa.edu) Carrie Stephan, MA, BSN, RN - (carrie-stephan@uiowa.edu) |
| University of McGill Montreal, Quebec | Jessica Cuerquis - (jessica.cuerquis@mcgill.ca) Audrey Trottier - (audrey.trottier@mail.mcgill.ca) |
| University of Rochester Medical Center Rochester, New York | Leann Lewis, MS - (Leann_Lewis@URMC.Rochester.edu) Marisa Rosenberg - (Marisa_Rosenberg@URMC.Rochester.edu) |
| University of Sao Paulo São Paulo, | Eliene Dutra Campos - (eliene.dcampos@hc.fm.usp.br) |
| University of Texas Health San Antonio San Antonio, Texas | Marlon Humbert Tamayo Muradas - (tamayomurada@uthscsa.edu) Edgar Morales - (moralese6@uthscsa.edu) |
| University of Utah Salt Lake City, Utah | Ryan Kennington - (ryan.kennington@hsc.utah.edu) Caroline Flood - (Caroline.Flood@hsc.utah.edu) |
| University of Washington Medical Center Seattle, Washington | Lilly Young - (eyoung@uw.edu) |
| Virginia Commonwealth University Richmond, Virginia | Resheed Reid - (resheed.reid1@vcuhealth.org) Levi Headrick - (levi.headrick@vcuhealth.org) |
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
OHB Contact - CMO@Oakhillbio.com
Rozycki, Henry
NCT03253263
HM20016299
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Inclusion Criteria:
• Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
• Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
• Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
Exclusion Criteria:
• Detectable major (or severe) congenital malformation identified before randomization.
• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
• Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
• Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
• Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
• Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
• The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
• Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
• Birth mother with known HIV or hepatitis (B, C, or E) infection.
DRUG: OHB-607
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
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Show 72 locations
Study Locations
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| Location | Contacts |
|---|---|
| Academisch Medisch Centrum Amsterdam Amsterdam-Zuidoost, North Holland | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital Chertsey, Surrey | |
| Azienda Ospedaliera Di Padova Padova, Veneto | |
| Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale Florence, | |
| Boston Children's Hospital Boston, Massachusetts | |
| Centro Hospitalar Lisboa Lisbon, | |
| Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. Porto, | |
| Chelsea and Westminster NHS Trust London, | |
| Children's Hospital of Orange County Orange, California | |
| Children's Minnesota - Children's Hospital and Clinics Saint Paul, Minnesota | |
| Children's Minnesota - Children's Hospital and Clinics - St. Paul Saint Paul, Minnesota | |
| Cork University Maternity Hospital Cork, Wilton | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Lombardy | |
| Fondazione Policlinico Universitario A Gemelli Roma, Emilia-Romagna | |
| Groupe Hospitalier Necker Enfants Malades Paris, | |
| Hopital Antoine Beclere Clamart, Hauts-de-Seine | |
| Hospital Garcia de Orta Almada, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Genova, | |
| Jackson Memorial Hospital Miami, Florida | |
| Kagoshima City Hospital Kagoshima, Kagoshima-ken | |
| Karolinska Solna Stockholm, | |
| Klinikum Nürnberg Nuremberg, | |
| Kurashiki Central Hospital Okayama, | |
| LAC USC Medical Center Los Angeles, California | |
| Liverpool Women's Hospital - PPDS Liverpool, | |
| Maastricht University Medical Center Maastricht, Limburg | |
| Maria Fareri Children's Hospital Valhalla, New York | |
| Mater Misericordiae Limited South Brisbane, | |
| Maternidade Alfredo da Costa Lisbon, | |
| Medical University of South Carolina Children Hospital Charleston, South Carolina | |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Mount Sinai Hospital New York, New York | |
| Nagano Children's Hospital Azumino, Nagano | |
| National Center for Child Health and Development Tokyo, | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Norfolk and Norwich University Hospital Norwich, Norfolk | |
| Norton Children's Hospital Louisville, Kentucky | |
| Ochsner Baptist Medical Center New Orleans, Louisiana | |
| Osaka Women's and Children's Hospital Izumi, Ôsaka | |
| Oulun Yliopistollinen Sairaala Oulu, | |
| Presidio Ospedaliero Di Treviso Ca' Foncello Treviso, | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Royal Hospital for Women Randwick, New South Wales | |
| Royal Women's Hospital Parkville, | |
| Sainte Justine Hospital Montreal, Quebec | |
| Saitama Medical Center Saitama, | |
| Saitama Prefectural Children's Medical Center Saitama, Saitama | |
| Showa Medical University Hospital Tokyo, | |
| Skanes universitetssjukhus Lund, | |
| St. Mary's Hospital Manchester, | |
| Tampa General Hospital Tampa, Florida | |
| Texas Children's Hospital Houston, Texas | |
| Tokyo Metropolitan Children's Medical Center Tokyo, | |
| Tufts Medical Center Boston, Massachusetts | |
| US Davis Sacramento, California | |
| UT Health Science Center San Antonio, Texas | |
| UVA Children's Hospital Charlottesville, Virginia | |
| Universitatsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitatsklinikum Leipzig Leipzig, Saxony | |
| University College London London, | |
| University Hospital Coventry Coventry, | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Cambridge Cambridge, | |
| University of Illinois at Chicago Chicago, Illinois | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Rochester Rochester, New York | |
| Virginia Commonwealth University - Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Westmead Hospital Northmead, New South Wales | |
| Wilhelmina Children Hospital-University Medical Center Utrecht Utrecht, |
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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Show 205 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| 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 | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| 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) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
Reference Study ID Number: DSC/14/2357/51 - patientadvocacy@italfarmaco.com
Harper, Amy
NCT03373968
HM20018448
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Inclusion Criteria:
• Must have participated in one of the previous studies with GIVINOSTAT in DMD and have attended the End of Study Visit or must have been screened in study DSC/14/2357/48 and met: * all the inclusion criteria and none of the exclusion criteria, * had a baseline vastus lateralis muscle fat fraction (VL MFF) assessed by MRS in the range ≤5% or \>30%, i.e. included in"off-target" group, * never been randomized because, the enrollment in the off target group was completed.
• Aged ≥6 years old;
• Are able to give informed assent and/or consent in writing signed by the subject and/or parent/legal guardian (according to localregulations);
• Subjects must be willing to use adequate contraception: * Contraceptive methods must since the previous GIVINOSTAT study through 3 months after the last dose of study drug, and include the following: * True abstinence (absence of any sexual intercourse), when in line with the preferred and usual lifestyle of the subject. * Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. * Condom with spermicide and the female partner must use an acceptable method of contraception, such as an oral, * transdermal, injectable or implanted steroid-basedcontraceptive, or a diaphragm or a barrier method of contraception in conjunction with spermicidal jelly such asfor example cervical cap with spermicide jelly.
Exclusion Criteria:
• Use of any pharmacologic treatment, other than corticosteroids, that might have had an effect on muscle strength or function within 3 months prior to be enrolled in this study (e.g., growth hormone); Vitamin D, calcium, and any other supplements will be allowed;
• Use of any current investigational drug other than Givinostat;
• Have presence of other clinically significant disease, which, in the Investigator's opinion, could adversely affect the safety of the subject, making it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results;
• Have a diagnosis of other uncontrolled neurological diseases or presence of relevant uncontrolled somatic disorders that are not related to DMD;
• Have platelets count, White Blood Cell and Hemoglobin at screening \< Lower Limit of Normal (LLN)\* (for abnormal screening laboratory test results (\
• Have inadequate renal function, as defined by serum Cystatin C \>2 x the upper limit of normal (ULN) at screening visit\*. If the value is \>2 x ULN, the serum Cystatin C will be repeated once; if the repeated test result is still \>2 x ULN, the subject should be excluded);
• Have heart failure (New York Heart Association Class III or IV)
• Have a current liver disease or impairment, including but not limited to an elevated total bilirubin\* (i.e. \> 1.5 x ULN), unless secondary to Gilbert disease or pattern consistent with Gilbert's;
• Have a baseline QTcF \>450 msec, (as the mean of 3 consecutive readings 5 minutes apart) or history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome);
• Have a psychiatric illness/social situation rendering the potential subject unable to understand and comply with the muscle function tests and/or with the study protocol procedures.
• Have any hypersensitivity to the components of study medication;
• Have a sorbitol intolerance or sorbitol malabsorption or have the hereditary form of fructose intolerance. * the Investigators to evaluate these exclusion criteria can use the laboratory results obtained within 5 months from V1, to allow the continuity of the treatment. It is worth noting, as soon as the site will receive the laboratory results done in screening/baseline (Visit 1) visit they will check the GIVINOSTAT dose and modify it as per protocol safety rules and/or dosage modifications rules.
DRUG: Givinostat
Duchenne Muscular Dystrophy
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Study Locations
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| Location | Contacts |
|---|---|
| A.O.U. Policlinico G. Martino, U.O.C. Neurologia e Malattie Neuromuscolari Messina, | |
| Alder Hey Children's Hospital NHS Trust Liverpool, UK | |
| CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest Nantes, | |
| Centro Clinico NeMO Fondazione Serena ONLUS Area SUD Milan, | |
| Child Health Research Institute Gainesville, Florida | |
| Clinic of Neurology and Psychiatry for Children and Youth - Neurology Department Dr. Subotic 6a, Belgrade, | |
| Connecticut Children's Medical Center, Neurology Division Hartford, Connecticut | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica Milan, | |
| Fondazione Policlinico Universitario "A.Gemelli", UOC Neuropsichiatria Infantile Roma, | |
| Holland Bloorview Kids Rehabilitation Hospital Toronto, Ontario | |
| Hospital Materno-Infantil Barcelona, | Francina Munell, MD - (francina.munell@vhir.org) |
| Hospital Universitari i Politècnic La Fe - Servicio Neurologia Valencia, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN) Liège, | |
| Hôpital Armand Trousseau I-Motion - Plateforme d'essais cliniques pédiatriques Bâtiment Lemariey - Porte 20 * 2ème étage 26 Avenue du Dr Arnold Nette Paris, | |
| IRCCS Istituto Neurologico Carlo Besta Milan, Lombardy | |
| Institute of Neurology - Schneider Children's Medical Center of Israel Kaplan, 14 Petah Tikva, | |
| Kinsmen Research Centre - Alberta Children's Hospital Calgary, Alberta | |
| Klinik- und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum HamburgEppendorf, Martinistr. 52 Hamburg, | |
| Klinikum der Universitat Munchen, Campus Innenstadt, Lindwurmstr. 4 München, | |
| Leiden University Medical Center LUMC, Albinusdreef 2 Leiden, | |
| MD Rare Disease Research, LLC Atlanta, Georgia | |
| Neuromuscular Pathology Unit - Hospital Sant Joan de Déu Esplugues de Llobregat, Barcellona | |
| Ospedale Pediatrico Bambino Gesù, Malattie Neuromuscolari e Neurodegenerative Roma, | Enrico Bertini, MD - (enricosilvio.bertini@opbg.net) |
| Radboud University Medical Centre Nijmegen, | |
| Rady Children's Hospital center - UCSD Department of Neuroscience San Diego, California | |
| Shriners Hospitals for Children Portland, Oregon | |
| The Children's Hospital of Philadelphia Colket Translational Research Building Philadelphia, Pennsylvania | |
| The John Walton Muscular Dystrophy Research Centre Newcastle upon Tyne, | |
| The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust Gobowen, | |
| The University of British Columbia, Children's and Womens Health Centre of BC Branch Vancouver, British Columbia | |
| U.O.S.D. Centro Traslazionale di Miologia e Patologie Neurodegenerative, Building 16 - ground floor IRCCS Istituto Giannina Gaslini, Genova, | Claudio Bruno, MD - (claudio2246@gmail.com) |
| UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD London, | |
| University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology Leuven, | |
| University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation Sacramento, California | |
| University of Iowa Children's Hospital Iowa City, Iowa | |
| Universitätsklinikum Essen - Kinder-und Jugendmedizin Neuropadiatrie Essen, | |
| Virginia Commonwealth University Childrens Hospital of Richmond at Richmond, Virginia | |
| Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111 St Louis, Missouri |
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA) (RESTORE)
Novartis Gene Therapies - novartis.email@novartis.com
Johnson, Nicholas, E
NCT04174157
HM20015046
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Inclusion Criteria:
* Patients treated with OAV-101 with a genetically confirmed diagnosis of SMA regardless of the date of diagnosis.
* Appropriate consent/assent has been obtained for participation in the registry
Exclusion Criteria:
• Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA. Note: Patients who are participating in a Compassionate Use Program (CUP) for OAV-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of a genetic or clinical diagnosis of SMA.
OTHER: Prospective observational registry, DRUG: Zolgensma
Spinal Muscular Atrophy (SMA)
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Show 99 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adventist Health System - Florida Orlando, Florida | |
| Aichi Medical University Hospital Nagakute-shi, Aichi, | |
| Akron Children's Hospital Akron, Ohio | |
| Almazov National Medical Research Centre Saint Petersburg, | Natalia Petrova, MD - (natalja5@yandex.ru) |
| Arkansas Children's Hospital Little Rock, Arkansas | Kapil Arya - (karya@uams.edu) |
| Atlantic Health System Morristown, New Jersey | Darius Adams, MD - (adamsd@mail.amc.edu) |
| CHRISTUS Health Tyler, Texas | Melissa Svoboda, MD - (melissa.svoboda@bcm.edu) |
| CHUC - Hospital Pediatrico Coimbra, | Joana Ribeiro, MD - (10675@chuc.min-saude.pt) |
| Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku, | |
| Centro Hospitalar Universitaria de Lisboa Central, EPE Lisboa, | Jose Pedro Vieira, MD - (Jose.vieira@chlc.min-suade.pt) |
| Centro Hospitalar Universitario Lisboa Norte, EPE Lisboa, | Teresa Moreno, MD - (ped.ensaioscaml@gmail.com) Joana Coelho, MD - (joanamalveirocoelho@gmail.com) |
| Centro Hospitalar Universitario de Porto, EPE Porto, | Cristina Garrido, MD - (cgarridopt@gmail.com) |
| Centro Hospitalar Universitario de Sao Joao, EPE Porto, | Raquel Carvalho Sousa, MD - (Rccarvalhosousa@gmail.com) |
| Centrul de Recuperare pentru Copii dr. Nicolae Robanescu Bucharest, | Madalina Cristina Leanca, MD - (mada332@yahoo.com) |
| Chang Gung Memorial Hospital Linkou Branch Taoyuan City Singapore, | I-Jun CHOU, MD - (ijun@adm.cgmh.org.tw) |
| Chiba children's Hospital Chiba-shi, Chiba | |
| Child Neurology Consultants of Austin Austin, Texas | |
| Children's Health Dallas, Texas | |
| Children's Hospital Colorado Aurora, Colorado | Margaret Finlay - (margaret.finlay@childrenscolorado.org) |
| Children's Hospital of Los Angeles Glendale, California | Martha Arellano-Garcia - (margarcia@chla.usc.edu) Claudia Dozal - (cdozal@chla.usc.edu) |
| Children's Hospital of Orange County Orange, California | Amanda Fernandez, MD - (afernandez@choc.org) Linda Do - (Linh.Do@choc.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Rupa Nallamothu - (rnallamothu@mcw.edu) Rebecca Rehborg - (rrehborg@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Cassandra Todd - (Cassandra.Todd@chkd.org) |
| Children's University Hospital-UCD School of Medicine Scoil an Leighis Dublin, | Declan O Rourke, MD - (declan.orourke@cuh.ie) |
| China Medical University Hospital Taichung, TW | I-Ching Chou, MD - (004009@tool.caaumed.org.tw) - (004009@tool.caaumed.org.tw) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Emily Hunsaker - (emily.hunsaker@cchmc.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | Hendriana Nielsen - (HNielsen@connecticutchildrens.org) James Santanelli - (jsantanelli@connecticutchidlrens.org) |
| Cook Children's Forth Worth, Texas | Kayla Blough - (Kayla.blough@cookchildrens.org) |
| Dokkyo Medical University Saitama Medical Center Saitama, Koshigaya, | |
| Duke Health Durham, North Carolina | Karen Cornett - (k.cornett@duke.edu) |
| Fujita Health University Hospital Toyoake, Aichi-ken | |
| Fukui Prefectural Hospital Fukui-shi, Fukui | |
| General Hospital of Thessaloniki Ippokrateio Thessaloníki, | Dimitrios Zafeiriou, MD - (dizafeir@auth.gr) |
| Gifu Prefectural General Medical Center Gifu, | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Britt Stroud, MD - (britt.stroud@leehealth.org) Molly Arnstrom - (Molly.arnstrom@leehealth.org) |
| Hamamatsu University School of Medicine, University Hospital Hamamatsu, | |
| Indiana University Health University Hospital (IUHUH) Indianapolis, Indiana | Marcia Felker, MD - (mamccann@iupui.edu) Leanne Dunn - (lkhernan@iu.edu) |
| Jackson South Medical Center Palmetto Bay, Florida | Paula Schleifer, MD - (pschleifer@fcneurology.net) |
| Jichi Medical University Hospital Tochigi, | |
| Kagawa University Hospital Kagawa, | |
| Kanagawa Children's Medical Center Yokohama, Kanagawa | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | Yuh-Jyh Jong, MD - (yjjong@gap.kmu.edu.tw) |
| Kumamoto University Hospital Kumamoto-Shi Chuo-Ku, Kumamoto | |
| Kurume University Hospital Fukuoka, | |
| Kyungpook National University Hospital Daegu, | Jeong Jin Yun, SC - (sylyu01@naver.com) |
| Loma Linda University Health Loma Linda, California | |
| Methodist Le Bonheur Healthcare Germantown, Tennessee | Farimah Salami - (Farimah.Salami@lebonheur.org) |
| Miyagi Children's Hospital Sendai-shi, Miyagi | |
| Multicare Health System Tacoma, Washington | Beky Stone - (Becky.Stone@multicare.org) |
| National Taiwan University Hospital Taipei, | Yin-Hsiu CHIEN, MD - (chienyh@ntu.edu.tw) |
| Nationwide Children's Hospital Columbus, Ohio | Megan Waldrop - (Megan.WAldrop@nationwidechildrens.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Nikko Memorial Hospital Hokkaido, | |
| Obihiro Kosei Hospital Hokkaido, Obihiro-shi | |
| Oklahoma University Medical Center Oklahoma City, Oklahoma | |
| Oregon Health and Science University Portland, Oregon | Bryn McCarthy - (McCarbry@ohsu.edu) |
| Penn State Hershey Hershey, Pennsylvania | Ellen Stoute - (estoute@pennstatehealth.psu.edu) Ashutosh Kumar, MD - (akumar5@pennstatehealth.psu.edu) |
| Penteli Children's Hospital Penteli, Attikis | Chrysanthi Tsimakidi - (Chrysanthit@hotmail.com) |
| Phoenix Children's Hospital Phoenix, Arizona | Alison Lane - (alane@phoenixchildrens.com) |
| Prisma Health Columbia, South Carolina | Addie Hunnicutt Hunnicutt - (ahunnicutt@ghs.org) Addie Hunnicutt - (ahunnicutt@ghs.org) |
| Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do | Yunjin Lee, MD - (jinnyeye@hanmail.net) |
| Rady Children's Hospital San Diego San Diego, California | Chamindra Konersman, MD - (ckonersman@health.ucsd.edu) Napat Intarachumnum - (nintarachumnum@health.ucsd.edu) |
| Samsung Medical Centre Seoul, | Min Jeong Kim, SC - (tgkimmj@naver.com) |
| Sapporo Medical University Hospital Sapporo, Hokkaid | |
| Schneider- Children's Medical Center Petah tikva, | Sharon Aharoni, MD - (Sharonah@clalit.org.il) |
| Seattle Children's Seattle, Washington | Marissa Robertson - (Marissa.Robertson@seattlechildrens.org) |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | Anna Cho, MD - (annacho77@snu.ac.kr) |
| Seoul National University Children's Hospital Seoul, | Miae Kim, SC - (sellykma@snuh.org) |
| Severance Hospital Seodaemun-gu, | Hoonchul Kang, MD - (HIPO0207@yuhs.ac) |
| Shiga Medical Center for Children Moriyama-shi, Shiga | |
| Soroka Medical Centre Be'er Sheva, | Iris Noyman, MD - (IRISN@clalit.org.il) |
| Spitalul Clinic de Psihiatrie Bucharest, | Loana Minciu, MD - (Iminciu@yahoo.com) |
| St. Sophia Children's Hospital Thessaloniki, | Maria Roser-Pons, MD - (roserpons@med.uoa.gr) |
| Taipei Veterans General Hospital Taipei, | Dau-Ming NIU, MD - (dmniu1111@yahoo.com.tw) |
| Tel-Aviv Sourasky Medical Center Tel Aviv, | Aviva Fattal, MD - (afatal@post.tau.ac.il) |
| Texas Children's Hospital Houston, Texas | Felize Singleton - (felize.singleton@bcm.edu) |
| The State University of New York Stony Brook, New York | Christine Pol - (Christiana.Pol@stonybrookmedicine.edu) |
| Tokyo Medical University Hospital Shinjuku-Ku, | |
| University General Hospital Attikon Athens, Attica | Argyrios Dinopoulos, MD - (argidino@yahoo.com) |
| University Hospitals Cleveland, Ohio | |
| University of California Davis Health System Sacramento, California | Rachel (Ja Yoon) Baek - (jrbaek@ucdavis.edu) |
| University of California Los Angeles Health Los Angeles, California | Huynh Jennifer - (JenniferH@mednet.ucla.edu) |
| University of Iowa Iowa City, Iowa | Chandra Miller - (Chandra-miller@uiowa.edu) Carrie Stephan - (Carrie-stephan@uiowa.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Rebecca Clay - (rclay@kumc.edu) |
| University of Louisville Louisville, Kentucky | Lauren Evanczyk - (Lauren.evanczyk@nortonhealthcare.org) |
| University of Minnesota Minneapolis, Minnesota | Seth Stafki, MD - (stafk006@umn.edu) |
| University of Missouri Health System Columbia, Missouri | Anne Bonnett - (bonnetta@health.missouri.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Emma Sekscinski - (ecs112@pitt.edu) |
| University of Rochester Medical Center Rochester, New York | Bohoon Lee - (Bohoon_Lee@URMC.Rochester.edu) Kim Hart Kim_ - (Hart@URMC.Rochester.edu) |
| University of Utah Salt Lake City, Utah | Sarah Moldt - (sarah.moldt@hsc.utah.edu) |
| University of Virginia Health System Charlottesville, Virginia | Chelsea Masterson - (CDM5FA@hscmail.mcc.virginia.edu) |
| University of Wisconsin Madison, Wisconsin | Maggie Chilsen - (mchilsen@clinicaltrials.wisc.edu) |
| Uniwersytecki Szpital Dzieciec Lublin, | Magdalena Chroscinska-Krawczyk, MD - (magdalenachk@wp.pl) |
| Valley Children's Healthcare Madera, California | Raymund David, MD - (RDavid@valleychildrens.org) |
| Virginia Commonwealth University Health System Richmond, Virginia | Ana Rosa Rezeq - (Anarosa.rezeq@vcuhealth.org) |
| Washington University School of Medicine in St. Louis St Louis, Missouri | Natalie Goedeker - (ngoedeker@wustl.edu) |
| Wolfson Medical Center Holon, | Mira Ginsberg, MD - (miraginsberg@gmail.com) |
| Yale-New Haven Health System New Haven, Connecticut | Catherine Tsao - (catherine.tsao@yale.edu) |
| Yongin Severance Hospital Yongin-si, | Lae-song Noh, SC - (YI771998@yuhs.ac) |
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System (FSGSALLAGE)
Ayaka Kitamura - Ayaka.Kitamura1@kaneka.co.jp
NCT04065438
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Inclusion Criteria:
A patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when:
• Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2.
or
• The patient is post renal transplantation.
Exclusion Criteria:
General Exclusion Criteria
• Patient is greater than 75 years of age at the start of the treatment period or less than 22
• The patient is unwilling or unable to sign and date the informed consent
• Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)
• Unable or unwilling to comply with the follow-up schedule
• Simultaneously participating in another investigational drug or device study
• Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria
• Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
• Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure
• Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
• Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
• Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
• Extracorporeal circulation therapy with LIPOSORBER® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for age, gender, and height.
• Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
• Functional thyroid disease or liver abnormalities
• Unresolved systemic or local infection that could affect the clinical study outcomes
DEVICE: LIPOSORBER® LA-15
Focal Segmental Glomerulosclerosis
FSGS, Liposorber
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Show 10 locations
Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | Rupesh Raina, MD - (apokelsek@akronchildrens.org) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | |
| Loma Linda University Children's Hospital Loma Linda, California | |
| Loma Linda University Hospital Loma Linda, California | Daisy Sekly - (DSekly@llu.edu) |
| Medical University of South Carolina Charleston, South Carolina | Linda Walker - (walkerlp@musc.edu) |
| Medical University of South Carolina Children's Hospital Charleston, South Carolina | |
| Nemours/Alfred I DuPont Hospital for Children Wilmington, Delaware | Joshua J Zaritsly, MD - (joshua.zaritsky@nemours.org) |
| University of North Carolina Chapel Hill, North Carolina | Anne Froment - (anne_froment@med.unc.edu) |
| Weill Cornell Medicine / NewYork-Presbyterian New York, New York |
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
Weir, Caryn, R - cweir@vcu.edu
Maher, Keri
NCT04315324
HM20021956
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Inclusion Criteria:
* Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are \>= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry
* Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have \>= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible
* Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients \< 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation)
* A standard chemotherapy induction regimen is defined as any program of treatment that includes:
* Vincristine and corticosteroids plus at least one more chemotherapy agent
* Cytarabine and anthracycline, or
* High dose cytarabine (defined as at least 1 gr/m\^2 per individual dose unless adjustments were required for renal/liver function)
* Patients must have no evidence of central nervous system disease within 28 days prior to registration based on cerebrospinal fluid (CSF) studies. Patients with clinical signs or symptoms consistent with central nervous system (CNS) involvement must have a lumbar puncture which is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Patients with CNS1 or CNS2 are eligible; however patients with CNS3 are not eligible
* Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture. This may count as the first dose of intrathecal therapy required as part of the study
* Prior nelarabine therapy is not required. In addition, for patients ≥ 18 years of age who received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy
* Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for corticosteroids, oral 6-mercaptopurine, oral methotrexate, vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who have received radiation therapy, at least 7 days must have elapsed from the end of radiation prior to registration and participants must not currently be experiencing toxicities from radiation therapy
* Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration
* Patients must have no evidence of active \>= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD. Patients must have no history of extensive GVHD of any severity within 90 days prior to registration. Patients who are post-transplant must be off calcineurin inhibitors for at least 21 days to be eligible. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ
* Patients must be \>= 12 years of age
* Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients \< 16 years of age must have a Lansky score of ≥ 50
* Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration
* Patients ≥ 18 years of age must have creatinine clearance \> 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation
* Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m\^2
* Patients must have direct bilirubin =\< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration
* Patients must have alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN) or =\< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration
* Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements)
* From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements)
* Patients must be able to safely discontinue use of strong inhibitors/inducers of CYP3A4 or PgP-g-p and must be able to safely discontinue use of naproxen for 48 hours before and after each dose of OBI-3424
* Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
* Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
* Patients with known history of hepatitis C virus (HCV) infection may be eligible provided that they have an undetectable HCV viral load within in 28 days prior to registration. Patients may be currently receiving treatment. (HCV viral load testing is required only for patients with known HCV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
* Patients must not have a known history of prolonged QT interval by Fridericia (QTcF) (interval \> 450 msec for males; \> 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval \> 450 msec for males; \> 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized
* Patients must not be pregnant or nursing due to the teratogenic potential of the drug used on this study. Females of reproductive potential must have a negative serum pregnancy test within 14 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. 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
* Patients must not have other active malignancies for which they have received treatments within 6 months prior to registration excluding localized malignancies that do not require systemic treatment
* Patients must agree to have bone marrow and blood specimens submitted for MRD testing
* Patients must be offered the opportunity to participate in specimen banking. With patient consent, residuals from specimens submitted will be retained and banked for future research
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with fedral, local, institutional and Central Institutional Review Board (CIRB) guidelines unless they are unable to provide consent based on age (\< 18 years) or based on impaired decision-making capabilities. For patients \< 18 years of age or with impaired decision making capabilities, parents or other legally authorized representatives must sign and give informed consent on behalf of study participants in accordance with applicable federal, local, institutional and CIRB regulations
* 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
* This trial will use a slot reservation system to enroll the Phase I portion of the study. Patients planning to enroll at this phase of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation DRUG: AKR1C3-activated Prodrug AST-3424, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Computed Tomography
Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia, Refractory T Lymphoblastic Lymphoma, T Lymphoblastic Lymphoma
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Show 163 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | |
| 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 | |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| 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) |
| Cambridge Medical Center Cambridge, Minnesota | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| 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 Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| 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 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) |
| 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) |
| 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) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Desert West Surgery Las Vegas, Nevada | |
| Duke University Medical Center Durham, North Carolina | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| 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 | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Vegas Tenaya 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) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| Health Partners Inc Minneapolis, Minnesota | |
| HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada | |
| Hennepin County Medical Center Minneapolis, Minnesota | |
| 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) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| 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) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lakeview Hospital Stillwater, Minnesota | |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Prostate Cancer Center Las Vegas, Nevada | 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 | |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| 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 | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | |
| Monticello Cancer Center Monticello, Minnesota | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| New Ulm Medical Center New Ulm, Minnesota | |
| North Memorial Medical Health Center Robbinsdale, Minnesota | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Regions Hospital Saint Paul, Minnesota | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Rice Memorial Hospital Willmar, Minnesota | |
| Ridgeview Medical Center Waconia, Minnesota | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Saint Francis Regional Medical Center Shakopee, Minnesota | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| 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) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | |
| United Hospital Saint Paul, Minnesota | |
| Unity Hospital Fridley, Minnesota | |
| University Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 Chicago Comprehensive Cancer Center Chicago, Illinois | |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | |
| 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 | |
| University of Illinois Chicago, Illinois | |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| 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 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 Washington Medical Center - Montlake Seattle, Washington | |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT01790152
HM20000463
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Inclusion Criteria:
Study Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV
* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS
* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)
* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia/lymphoblastic lymphoma \[P9404, high-risk DFCI 95-01\] or Hodgkin lymphoma \[P9425/P9426\])
* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation
* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \[also includes fields directed towards the neck, upper abdomen, or spine\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible
* STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \[COG?s\] Statistics and Data Center \[SDC\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)
* STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis
* STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM III: OSTEOSARCOMA SURVIVORS
* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and/or parents/legal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors
* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:
* Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible
* \< 31 years of age at time of initial osteosarcoma diagnosis
* Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002
* No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis
* Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria
* No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies
* No exposure to DRZ at any point in time
* All patients and/or their parents or legal guardians must sign a written informed consent
* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and/or radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year
* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \[DICOM\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable
* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)
* Based on echocardiography, must have either left ventricular fractional shortening =\< 28.0% or ejection fraction =\< 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection
* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \[ACE\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months
* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met OTHER: Assessment of Therapy Complications, OTHER: Laboratory Biomarker Analysis, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Hodgkin Lymphoma in Remission, Leukemia in Remission, Lymphoblastic Lymphoma, Osteosarcoma, Recurrent Leukemia, Recurrent Lymphoma, Recurrent Malignant Neoplasm
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See this study on ClinicalTrials.gov
Show 79 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| 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 | |
| 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 - (kim.williams3@prismahealth.org) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (aselegue@email.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | |
| Centre Hospitalier Universitaire de Quebec Québec, | |
| Children's Healthcare of Atlanta - Egleston Atlanta, Georgia | Site Public Contact - (Leann.Schilling@choa.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| 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) |
| Columbia Regional Columbia, Missouri | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | |
| Hurley Medical Center Flint, Michigan | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (sverwys@mmc.org) |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (Karen.Smith3@HCAHealthcare.com) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | |
| Nemours Children's Hospital Orlando, Florida | |
| 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) |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rhode Island Hospital Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (Katelynn.Colgain@baycare.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Mary's Hospital Rhinelander, Wisconsin | |
| San Jorge Children's Hospital San Juan, | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.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) |
| 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 | |
| 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 Florida Health Science Center - Gainesville Gainesville, Florida | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| 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) |
| Valley Children's Hospital Madera, California | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy (REACH CDM X)
Howell, Jodie - jodie.howell@vcuhealth.org
Johnson, Nicholas, E
NCT05004129
HM20023901
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Inclusion Criteria:
Subjects who do not enter this study directly from completing the AMO-02-MD-2-003 study (i.e. subjects who did not complete AMO-02-MD-2-003, subjects who completed AMO-02-MD-2-003 but did not directly rollover or subjects who are re-entering AMO-02-MD-2-004), will not be considered eligible for the study without meeting all of the criteria below:
• Subjects under study must be individuals with a diagnosis of Congenital or Childhood Onset DM1.
• Diagnosis must be genetically confirmed
• Subjects must be male or female aged ≥6 years to ≤45 years at Screening
• Subjects must have a Clinical Global Impression - Severity (CGI-S) score of 3 or greater at Screening (V-1)
• Written, voluntary informed consent must be obtained before any study related procedures are conducted. Where a parent or legally authorized representative (LAR) provides consent, there must also be assent from the subject (as required by local regulations)
• Subject's caregiver must be willing and able to support participation for duration of study
• Subject must be willing and able to comply with the required food intake restrictions as outlined per protocol Subjects entering directly from completing the antecedent AMO-02-MD-2-003 study will not be considered eligible for the study without meeting all of the criteria below:
• Subjects who have completed the antecedent AMO-02-MD-2-003 study through V11
• Written, voluntary informed consent must be obtained before any study related procedures are conducted. Where a parent or LAR provides consent, there must also be assent from the subject (as required by local regulations)
• Subject's caregiver must be willing and able to support participation for duration of study
• Subject must be willing and able to comply with the required food intake restrictions as outlined per protocol Key
Exclusion Criteria:
• Body mass index (BMI) less than 13.5 kg/m² or greater than 40 kg/m²
• New or change in medications/therapies within 4 weeks prior to Eligibility/Baseline Visit
• Use within 4 weeks prior to Eligibility/Baseline Visit of strong CYP3A4 inhibitors (eg.clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir)
• Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window (e.g. warfarin and digitoxin)
• Current enrollment in a clinical trial of an investigational drug or enrollment in a clinical trial of an investigational drug in the last 6 months other than the AMO-02- MD-2-003 study
• Existing or historical medical conditions or complications (eg. neurological, cardiovascular, renal, hepatic, gastrointestinal, endocrine or respiratory disease) that may impact the interpretability of the study results
• Hypersensitivity to tideglusib or any components of its formulation including allergy to strawberry
DRUG: Tideglusib
Congenital Myotonic Dystrophy
Tideglusib, AMO-02-MD-2-004, Congenital Myotonic Dystrophy, Myotonic Dystrophy, Dystrophia Myotonica, Myotonia Atrophica, Myotonia Dystrophica, Myotonic Dystrophy, Congenital, Steinert Disease, Steinert Myotonic Dystrophy, Steinert's Disease
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Show 14 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arkansas Children's Hospital Little Rock, Arkansas | Annette Guy - (GuyEA@archildrens.org) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| Children's Hospital London Health Sciences Centre (LHSC) London, Ontario | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | Emilie Hill-Smith - (ehillsmith@cheo.on.ca) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | |
| Lurie's Children's Hospital Chicago, Illinois | Joseph Alberts - (jalberts@luriechildrens.org) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| New Zealand Clinical Research (NZCR) Auckland, | |
| Stanford University Palo Alto, California | |
| The Bright Alliance Randwick, New South Wales | AMO Study Coordinator - (SCHN-SCHClinicalTrials@health.nsw.gov.au) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| University of California, Los Angeles (UCLA) Los Angeles, California | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | Laura Knosp - (laura-knosp@uiowa.edu) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Heather DiCostanzo - (follhl@upmc.edu) Caitlyn Daley - (catilyn.daley@reachcdm.com) |
| University of Rochester - Medical Center Rochester, New York | James Hilbert - (james_hilbert@URMC.Rochester.eud) Caitlyn Daley - (caitlyn.daley@reachcdm.com) |
| University of Utah Clinical Neurosciences Center Salt Lake City, Utah | Domink May - (dominik.may@hsc.utah.edu) Caitlyn Daley - (catilyn.daley@reachcdm.com) |
| Virginia Commonwealth University-Department of Neurology - Muscular Dystrophy Translational Research Program Richmond, Virginia |
Trifecta-Kidney cfDNA-MMDx Study
Konrad S Famulski, PhD - konrad@ualberta.ca
NCT04239703
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Inclusion Criteria:
* All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study.
Exclusion Criteria:
* Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients. DIAGNOSTIC_TEST: MMDx, DIAGNOSTIC_TEST: Prospera, DIAGNOSTIC_TEST: HLA antibody
Kidney Transplant Rejection
donor derived cell-free DNA, blood, kidney biopsy
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Show 31 locations
Study Locations
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| Location | Contacts |
|---|---|
| Barnes-Jewish Hospital, Washington University at St. Louis St Louis, Missouri | Andrew Malone - (amalone@wustl.edu) |
| Centre of Nephrology, Vilnius University Hospital Santaros Klinikos Vilnius, | Alvita Vickiene - (alvita.gincaite@gmail.com) |
| Charite-Medical University of Berlin Department of Nephrology Berlin, | Klemens Budde, MD - (klemens.budde@charite.de) Monique Greiner-Pol - (monique.greiner-pol@charite.de) |
| Cleveland Clinic Cleveland, Ohio | Debra Camino - (caminod@ccf.org) |
| Department of Nephrology and Transplantation Medical University in Bialystok Bialystok, | |
| Department of Nephrology, The Royal Melbourne Hospital 1 South East Melbourne, | Peter D Hughes, MD - (peter.hughes@mh.org.au) |
| Department of Nephrology, Transplantation and Internal Medicine, University Hospital n.2 Szczecin, | Leszek Domański, MD - (domanle@pum.edu.pl) |
| Department of Nephrology, University Medical Centre Ljubljana, | Nika Kojc, MD - (nika.kojc@mf.uni-lj.si) |
| Department of Transplantation and General Surgery, Wojewodzki Hospital Poznan, | Maciej Glyda, MD - (glydam@wp.pl) |
| Detroit Medical Center, Harper University Hospital of Wayne State University Detroit, Michigan | Rajeev Sharma, MD - (rasharma@med.wayne.edu) |
| Division of Nephrology & UW Organ Transplant Center University of Washington Seattle, Washington | Chris Blosser, MD - (CBlosser@nephrology.washington.edu) |
| Henry Ford Hospital Detroit, Michigan | Iman Francis - (Ifranci1@hfhs.org) |
| Institute for Clinical and Experimental Medicine (IKEM) Czechia, Praha 4 | Petra Hruba, MD - (hrup@ikem.cz) |
| Intermountain Transplant Services Murray, Utah | Jake Krong - (Jake.Krong@imail.org) |
| Medical University of Gdańsk Klinika Nefrologii Transplantologii i Chorób Wewnętrznych Gdansk, | Andrzej Chamienia, MD - (chamien@gumed.edu.pl) |
| Medical University of Silesia Katowice, | Grzegorz Piecha, MD - (g.piecha@outlook.com) |
| Medical University of Warsaw, Department of Transplantation Medicine, Nephrology and Internal Diseases Warsaw, | Magdalena Durlik, MD - (magdalena.durlik@wum.edu.pl) |
| Pomeranian Medical University, Samodzielny Publiczny Woj. Szpital Zespolony, Oddzial Nefrologii i Transplantacji Nerek Szczecin, | Marek Myślak, MD Phd - (marek.myslak@pum.edu.pl) |
| ST. Paul's Hospital, 6A Providence Building, 1081 Burrard Street Vancouver, British Columbia | Angela Ogniben - (AOgniben@providencehealth.bc.ca) |
| Tampa General Hospital Tampa, Florida | Natalie Remsen - (nremsen@tgh.org) |
| The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension Warsaw, | |
| The Johns Hopkins University, School of Medicine Baltimore, Maryland | Darin B Ostrander, PhD - (dostran1@jhmi.edu) |
| Transplant Medicine & Nephrology Clinic, Medical University of Warsaw Warsaw, | Agnieszka Perkowska-Ptasińska, MD PhD - (aggape@poczta.onet.pl) |
| University Hospital Merkur Renal Division Zagreb, | Zeljka Jurekovic, MD - (zeljka.jurekovic@gmail.com) |
| University Hospital Zurich Zurich, | |
| University Hospital nr1 Bydgoszcz, Klinika Transplantologii Bydgoszcz, | |
| University Hospitals Cleveland Medical Ctr. Cleveland, Ohio | Katherine R Carter - (Katherine.carter@uhhospitals.org) |
| University of Alberta, Department of Medicine Edmonton, Alberta | Soroush Shojai, MD - (shojai@ualberta.ca) |
| University of Maryland School of Medicine Baltimore, Maryland | Raissa Toure - (RToure@som.umaryland.edu) |
| Virginia Commonwealth University Medical Center Richmond, Virginia | Gaurav Gupta, MD - (ggupta@mcvh-vcu.edu) |
| Wroclaw Medical University, Department of Nephrology and Transplantation Medicine Wroclaw, | Mirosław Banasik, MD - (m.banasik@interia.pl) |
Preventing Firearm Violence in Youth: A Hospital-based Prevention Strategy
Nicholas Thomson - Nicholas.Thomson@vcuhealth.org
Thomson, Nicholas
NCT05078164
HM20022975
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Inclusion Criteria:
• Youth are aged 10-17 years and their adult caregivers are aged 18 years and older
• Receiving treatment in the hospital for a violence-related injury (e.g., gunshot wound) or referred to BTG/IVPP services
• English speaking
• Eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)
Exclusion Criteria:
• Youth are \< 10 years old
• Youth are \> 18 years old
• Prisoners
BEHAVIORAL: Bridging the Gap (BTG)
Violence in Adolescence
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Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia |
DMCRN-02-001: Assessing Pediatric Endpoints in DM1 (ASPIRE-DM1)
Ruby Langeslay - ruby.langeslay@vcuhealth.org
Johnson, Nicholas, E
NCT05224778
HM20023386
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Inclusion Criteria:
* Age neonate to 3 years 11 months at enrollment.
* A diagnosis of CDM, which is defined as children having symptoms of myotonic dystrophy in the newborn period (\<30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for more than 72 hours; and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500).
* Guardian is willing and able to sign consent and follow study procedures
Exclusion Criteria:
* Any other non-DM1 illness that would interfere with the ability or results of the study in the opinion of the site investigator
* Significant trauma within one month
* Internal metal or devices (exclusion for DEXA component)
* History of bleeding disorder or platelet count \<50,000
* History of reaction to local anesthetic Congenital Myotonic Dystrophy, CDM
Clinical Research, Myotonic dystrophy, Congenital Myotonic Dystrophy, CDM
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Show 5 locations
Study Locations
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| Location | Contacts |
|---|---|
| Centro Clinico Nemo Milan, | Michela Nani - (michela.nani@centrocliniconemo.it) Luca Mauro - (luca.mauro@centrocliniconemo.it) |
| University of California, Los Angeles Los Angeles, California | Merve Kaleli - (MKaleli@mednet.ucla.edu) Dennis Fernando - (DeFernando@mednet.ucla.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Cassidy Nelson - (cnelson15@kumc.edu) Michaela Walker - (mwalker20@kumc.edu) |
| University of Rochester Medical Center Rochester, New York | Jim Hilbert - (james_hilbert@urmc.rochester.edu) Jeanne Dekdebrun - (jeanne_dekdebrun@urmc.rochester.edu) |
| Virginia Commonwealth University Richmond, Virginia | Shantel Kyles - (shantel.brown@vcuhealth.org) Jodie Howell - (jodie.howell@vcuhealth.org) |
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Austin, Frances
NCT04322318
HM20023079
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Inclusion Criteria:
* Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
* Patients must be =\< 30 years old at study enrollment
* Patients with the following diagnoses are eligible for this study:
* Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
* Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:
* Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
* High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
* Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
* Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required
* Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
* Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy
* Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients must have a life expectancy of \>= 8 weeks
* Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:
* Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy
* Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the initial stratum assignment on APEC14B1-REN
* Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
* Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible
* Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
* Radiation therapy (RT): \>= 2 weeks (wks) must have elapsed for local palliative RT (small port); \>= 6 months must have elapsed if prior craniospinal RT or if \>= 50% radiation of pelvis; \>= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
* Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
* Peripheral absolute neutrophil count (ANC) \>= 750/uL (performed within 7 days prior to enrollment)
* Platelet count \>= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
* Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (performed within 7 days prior to enrollment)
* Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:
* Creatinine clearance or radioisotope GFR \>= 60 mL/min/1.73 m\^2 (performed within 7 days prior to enrollment)
* Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR \>= 60 mL/min/1.73 m\^2), or an adequate serum creatinine as per the following table:
* Age: Maximum Serum Creatinine (mg/dL)
* 1 month to \< 6 months: 0.4 (male and female)
* 6 months to \< 1 year: 0.5 (male and female)
* 1 to \< 2 years: 0.6 (male and female)
* 2 to \< 6 years: 0.8 (male and female)
* 6 to \< 10 years: 1 (male and female)
* 10 to \< 13 years: 1.2 (male and female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =\< ULN for patients whose total bilirubin \> 1.5 x ULN (performed within 7 days prior to enrollment)
* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age or =\< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)
* Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)
Exclusion Criteria:
* Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
* Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
* For patients with high-risk or very high-risk relapsed FHWT:
* Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \< 16 mmol/L and serum phosphate =\< 2 mg/dL (or \< 0.8 mmol/L) without supplementation
* For stages 2-4 DAWT and standard-risk relapsed FHWT patients:
* Chronic inflammatory bowel disease and/or bowel obstruction
* Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial 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 PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, DRUG: Carboplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Etoposide, DRUG: Ifosfamide, DRUG: Irinotecan, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, RADIATION: Radiation Therapy, PROCEDURE: Surgical Procedure, DRUG: Topotecan, PROCEDURE: Transabdominal Ultrasound, DRUG: Vincristine, PROCEDURE: X-Ray Imaging
Anaplastic Kidney Wilms Tumor, Recurrent Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor
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Show 204 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) |
| 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) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (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) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| 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) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| 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) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| 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 | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | |
| 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) |
| 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 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) |
| 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) |
| 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 | Site Public Contact - (research@sncrf.org) |
| 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) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.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 Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of 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 | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (cywhs.oncsec@health.sa.gov.au) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Mark Hall, MD - mark.hall@nationwidechildrens.org
NCT05267821
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Inclusion Criteria:
* ≥ 40 weeks corrected gestational age to \< 18 years; AND
* Admission to the PICU or CICU; AND
* Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
* Documented or suspected infection as the MODS inciting event.
Exclusion Criteria:
* Weight \<3kg; OR
* Limitation of care order at the time of screening; OR
* Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
* Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
* Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
* Peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR
* Known allergy to anakinra, or E. coli-derived products; OR
* Known pregnancy; OR
* Lactating females; OR
* Receipt of anakinra within the previous 28 days; OR
* Resolution of MODS by MODS Day 2; OR
* Previous enrollment in the TRIPS study. DRUG: Anakinra, DRUG: Placebo
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
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Show 32 locations
Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | Christopher Page-Goertz, MD - (CPage-Goertz@akronchildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Benioff Children's Hospital - Mission Bay San Francisco, California | |
| Benioff Children's Hospital - Oakland Oakland, California | |
| CS Mott Children's Hospital Detroit, Michigan | |
| Children's Hospital Colorado Aurora, Colorado | |
| Children's Hospital of Atlanta Atlanta, Georgia | Jocelyn Grunwell, MD, PhD - (jocelyn.grunwell@emory.edu) |
| Children's Hospital of Los Angeles Glendale, California | |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Minnesota Minneapolis, Minnesota | |
| Children's Hospital of Orange County Orange, California | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Julie Fitzgerald - (fitzgeraldj@chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Joseph Carcillo - (carcilloja@ccm.upmc.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Kirstin Henley - (kirstin.henley@christushealth.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Sonali Basu - (sbasu@childrensnational.org) |
| Children's Of Alabama Birmingham, Alabama | Michele Kong, MD - (mkong@uabmc.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Natalja Stanski, MD - (natalja.stanski@cchmc.org) |
| Duke University Durham, North Carolina | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | John Costello - (costello@musc.edu) |
| Mercy Children's Hospital Toledo, Ohio | |
| Nationwide Children's Hospital Columbus, Ohio | Mark Hall - (mark.hall@nationwidechildrens.org) |
| Pennsylvania State University Hershey, Pennsylvania | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Rady Children's Hospital San Diego, California | Nicole Coufal - (ncoufal@health.ucsd.edu) |
| Rainbow Babies and Children's Hospital Cleveland, Ohio | Kenneth Remy - (kenneth.remy@uhhospitals.org) |
| Riley Children's Hospital Indianapolis, Indiana | Daniel Cater, MD - (dancater@iu.edu) |
| Texas Children's Hospital Houston, Texas | |
| University of California, Davis Sacramento, California | MoonJoo Han, MD - (mjohan@ucdavis.edu) |
| University of Minnesota Minneapolis, Minnesota | |
| University of Texas Southwestern Dallas, Texas | Matthew Borgman - (Matthew.Borgman@UTSouthwestern.edu) |
| Virginia Commonwealth University Richmond, Virginia |
Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)
Vinay Nadkarni, MD, MS - nadkarni@chop.edu
NCT02708134
Show full eligibility criteria
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Inclusion Criteria:
* Patient received chest compressions for at least 1 minute
* Patient between gestational age ≥37 weeks and 18 years of age
Exclusion Criteria:
* Patient on veno-arterial extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event Cardiac Arrest, Cardiopulmonary Arrest
Chest compressions, Cardiopulmonary Resuscitation, Pediatric
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See this study on ClinicalTrials.gov
Show 61 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aichi Children's Health and Medical Center Ōbu, | |
| Akron Children's Akron, Ohio | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Calgary, | |
| All Children's Hospital St. Petersburg, Florida | |
| BC Children's Vancouver, British Columbia | |
| Boston Children's Boston, Massachusetts | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Children's Colorado Aurora, Colorado | |
| Children's Healthcare of Atlanta (CHOA) Atlanta, Georgia | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Vinay Nadkarni, MD, MS - (nadkarni@chop.edu) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Chldren's Hospital of Orange County Orange, California | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cohen Children's Medical Center Queens, New York | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dell Children's Medical Center Austin, Texas | |
| Erasmus MC - Sophia Children's Rotterdam, | |
| Great Ormond Street Hospital London, | |
| Gregorio Marañón General University Hospital Madrid, | |
| IRCCS Ospedale Pediatrico Bambino Gesu Rome, | |
| Instituto Roosevelt Bogotá, | |
| KK Women's & Children's Hospital Singapore, | |
| Kaiser Permanente Fresno, California | |
| Kentucky Children's Hospital Lexington, Kentucky | |
| King Chulalongkorn University Bangkok, | |
| Kobe Children's Hospital (Hyogo Prefectural) Kobe, | |
| Lurie Children's (Children's Hospital of Chicago) Chicago, Illinois | |
| Massachusetts General Hospital Lexington, Massachusetts | |
| Medical City Children's Hospital Dallas, Texas | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | |
| Morgan Stanley Children's Hospital New York, New York | |
| Mount Sinai Kravis Children's Hospital New York, New York | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Nebraska Medical Center Omaha, Nebraska | |
| Nemours Children's Hospital Orlando, Florida | |
| Perth Children's Hospital Perth, Western Australia | |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital San Diego, California | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Sabara Hospital Infantil São Paulo, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do | |
| St. Louis Children's Hospital St Louis, Missouri | |
| Stanford University Palo Alto, California | |
| Starship Children's Hospital Grafton, Auckland | |
| Stollery Children's Hospital Edmonton, | |
| Stony Brook University Hospital Stony Brook, New York | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Children's Hospital of San Antonio San Antonio, Texas | |
| The Johns Hopkins Hospital Baltimore, Maryland | |
| Tokyo Metropolitan Children's Medical Center Tokyo, | |
| University of Chicago, Comer Children's Hospital Chicago, Illinois | |
| University of Iowa Stead Family Children's Hospital Iowa City, Iowa | |
| University of North Carolina Chapel Hill, North Carolina | |
| University of Texas Southwestern Dallas, Texas | |
| Upstate Golisano Children's Hospital Syracuse, New York | |
| Valley Children's Hospital Madera, California |