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Active, not recruiting Phase 3 Interventional Results available

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

ClinicalTrials.gov ID: NCT02521493

Public ClinicalTrials.gov record NCT02521493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Study identification

NCT ID
NCT02521493
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
280 participants

Conditions and interventions

Eligibility (public fields only)

Age range
91 Days to 3 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 23, 2015 (Actual)
Primary completion
Jun 30, 2024 (Actual)
Completion
Jun 30, 2027 (Estimated)
Last update posted
Aug 19, 2026

2015 – 2027

United States locations

U.S. sites
169
U.S. states
47
U.S. cities
134
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Providence Alaska Medical Center Anchorage Alaska 99508 —
Banner Children's at Desert Mesa Arizona 85202 —
Phoenix Childrens Hospital Phoenix Arizona 85016 —
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 —
Kaiser Permanente Downey Medical Center Downey California 90242 —
Loma Linda University Medical Center Loma Linda California 92354 —
Miller Children's and Women's Hospital Long Beach Long Beach California 90806 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Valley Children's Hospital Madera California 93636 —
UCSF Benioff Children's Hospital Oakland Oakland California 94609 —
Kaiser Permanente-Oakland Oakland California 94611 —
Children's Hospital of Orange County Orange California 92868 —
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304 —
Sutter Medical Center Sacramento Sacramento California 95816 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
Rady Children's Hospital - San Diego San Diego California 92123 —
Naval Medical Center -San Diego San Diego California 92134 —
UCSF Medical Center-Mission Bay San Francisco California 94158 —
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California 90502 —
Children's Hospital Colorado Aurora Colorado 80045 —
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Yale University New Haven Connecticut 06520 —
Alfred I duPont Hospital for Children Wilmington Delaware 19803 —
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Broward Health Medical Center Fort Lauderdale Florida 33316 —
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 —
UF Health Cancer Institute - Gainesville Gainesville Florida 32610 —
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021 —
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 —
Palms West Radiation Therapy Loxahatchee Groves Florida 33470 —
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida 33136 —
Nicklaus Children's Hospital Miami Florida 33155 —
AdventHealth Orlando Orlando Florida 32803 —
Arnold Palmer Hospital for Children Orlando Florida 32806 —
Nemours Children's Hospital Orlando Florida 32827 —
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 —
Sacred Heart Hospital Pensacola Florida 32504 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 —
Saint Mary's Medical Center West Palm Beach Florida 33407 —
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 —
Memorial Health University Medical Center Savannah Georgia 31404 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Saint Luke's Cancer Institute - Boise Boise Idaho 83712 —
Lurie Children's Hospital-Chicago Chicago Illinois 60611 —
University of Illinois Chicago Illinois 60612 —
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637 —
Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois 60453 —
Advocate Children's Hospital-Park Ridge Park Ridge Illinois 60068 —
OSF Children's Hospital of Illinois Peoria Illinois 61637 —
Southern Illinois University School of Medicine Springfield Illinois 62702 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana 46260 —
Blank Children's Hospital Des Moines Iowa 50309 —
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 —
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 —
Norton Children's Hospital Louisville Kentucky 40202 —
Children's Hospital New Orleans New Orleans Louisiana 70118 —
Ochsner Medical Center Jefferson New Orleans Louisiana 70121 —
Eastern Maine Medical Center Bangor Maine 04401 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 —
Walter Reed National Military Medical Center Bethesda Maryland 20889-5600 —
Tufts Children's Hospital Boston Massachusetts 02111 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Baystate Medical Center Springfield Massachusetts 01199 —
UMass Memorial Medical Center - University Campus Worcester Massachusetts 01655 —
C S Mott Children's Hospital Ann Arbor Michigan 48109 —
Wayne State University/Karmanos Cancer Institute Detroit Michigan 48201 —
Henry Ford Health Saint John Hospital Detroit Michigan 48236 —
Michigan State University East Lansing Michigan 48823 —
Hurley Medical Center Flint Michigan 48503 —
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
Corewell Health Children's Royal Oak Michigan 48073 —
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 —
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 —
Mayo Clinic in Rochester Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
University of Missouri Children's Hospital Columbia Missouri 65212 —
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 —
Washington University School of Medicine St Louis Missouri 63110 —
Mercy Hospital Saint Louis St Louis Missouri 63141 —
University Medical Center of Southern Nevada Las Vegas Nevada 89102 —
Sunrise Hospital and Medical Center Las Vegas Nevada 89109 —
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada 89135 —
Summerlin Hospital Medical Center Las Vegas Nevada 89144 —
Renown Regional Medical Center Reno Nevada 89502 —
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Morristown Medical Center Morristown New Jersey 07960 —
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 —
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 —
Presbyterian Hospital Albuquerque New Mexico 87106 —
University of New Mexico Cancer Center Albuquerque New Mexico 87106 —
Albany Medical Center Albany New York 12208 —
Roswell Park Cancer Institute Buffalo New York 14263 —
NYU Langone Hospital - Long Island Mineola New York 11501 —
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 —
Mount Sinai Hospital New York New York 10029 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
NYP/Weill Cornell Medical Center New York New York 10065 —
University of Rochester Rochester New York 14642 —
Stony Brook University Medical Center Stony Brook New York 11794 —
State University of New York Upstate Medical University Syracuse New York 13210 —
Montefiore Medical Center - Moses Campus The Bronx New York 10467 —
New York Medical College Valhalla New York 10595 —
Mission Hospital Asheville North Carolina 28801 —
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 —
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 —
Novant Health Presbyterian Medical Center Charlotte North Carolina 28204 —
Duke University Medical Center Durham North Carolina 27710 —
East Carolina University Greenville North Carolina 27834 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Sanford Broadway Medical Center Fargo North Dakota 58122 —
Children's Hospital Medical Center of Akron Akron Ohio 44308 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Dayton Children's Hospital Dayton Ohio 45404 —
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Legacy Emanuel Children's Hospital Portland Oregon 97227 —
Oregon Health and Science University Portland Oregon 97239 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Penn State Children's Hospital Hershey Pennsylvania 17033 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
Rhode Island Hospital Providence Rhode Island 02903 —
Medical University of South Carolina Charleston South Carolina 29425 —
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 —
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 —
T C Thompson Children's Hospital Chattanooga Tennessee 37403 —
East Tennessee Childrens Hospital Knoxville Tennessee 37916 —
Saint Jude Children's Research Hospital Memphis Tennessee 38105 —
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 —
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 —
Texas Tech University Health Sciences Center-Amarillo Amarillo Texas 79106 —
Dell Children's Medical Center of Central Texas Austin Texas 78723 —
Driscoll Children's Hospital Corpus Christi Texas 78411 —
Medical City Dallas Hospital Dallas Texas 75230 —
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 —
El Paso Children's Hospital El Paso Texas 79905 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 —
Covenant Children's Hospital Lubbock Texas 79410 —
UMC Cancer Center / UMC Health System Lubbock Texas 79415 —
Children's Hospital of San Antonio San Antonio Texas 78207 —
Methodist Children's Hospital of South Texas San Antonio Texas 78229 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —
Primary Children's Hospital Salt Lake City Utah 84113 —
University of Vermont and State Agricultural College Burlington Vermont 05405 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Children's Hospital of The King's Daughters Norfolk Virginia 23507 —
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 —
Seattle Children's Hospital Seattle Washington 98105 —
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 —
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 —
Madigan Army Medical Center Tacoma Washington 98431 —
West Virginia University Charleston Division Charleston West Virginia 25304 —
Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin 54301 —
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02521493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 19, 2026 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02521493 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →