ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

ClinicalTrials.gov ID: NCT05457556

Public ClinicalTrials.gov record NCT05457556. 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 May 8, 2026, 10:44 PM EDT

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

Official title

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Study identification

NCT ID
NCT05457556
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
435 participants

Conditions and interventions

Interventions

  • Biospecimen Collection Procedure
  • Bone Marrow Aspiration Procedure
  • Busulfan Drug
  • Cyclophosphamide Drug
  • Echocardiography Test Procedure
  • Fludarabine Drug
  • Haploidentical Hematopoietic Cell Transplantation Procedure
  • Lapine T-Lymphocyte Immune Globulin Biological
  • Lumbar Puncture Procedure
  • Matched Unrelated Donor Hematopoietic Cell Transplantation Procedure
  • Melphalan Drug
  • Methotrexate Drug
  • Multigated Acquisition Scan Procedure
  • Mycophenolate Mofetil Drug
  • Myeloablative Conditioning Procedure
  • Quality-of-Life Assessment Other
  • Questionnaire Administration Other
  • Rituximab Biological
  • T-Cell Depletion Therapy Procedure
  • Tacrolimus Drug
  • Thiotepa Drug
  • Total-Body Irradiation Radiation

Procedure · Drug · Biological + 2 more

Eligibility (public fields only)

Age range
6 Months to 21 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
Mar 14, 2023
Primary completion
Jun 29, 2026
Completion
Jun 29, 2026
Last update posted
Dec 21, 2025

2023 – 2026

United States locations

U.S. sites
57
U.S. states
31
U.S. cities
52
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233
Phoenix Childrens Hospital Phoenix Arizona 85016
Arkansas Children's Hospital Little Rock Arkansas 72202-3591
City of Hope Comprehensive Cancer Center Duarte California 91010
Loma Linda University Medical Center Loma Linda California 92354
Children's Hospital Los Angeles Los Angeles California 90027
UCSF Benioff Children's Hospital Oakland Oakland California 94609
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304
UCSF Medical Center-Mission Bay San Francisco California 94158
Children's Hospital Colorado Aurora Colorado 80045
Yale University New Haven Connecticut 06520
Alfred I duPont Hospital for Children Wilmington Delaware 19803
Children's National Medical Center Washington D.C. District of Columbia 20010
UF Health Cancer Institute - Gainesville Gainesville Florida 32610
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207
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
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701
Lurie Children's Hospital-Chicago Chicago Illinois 60611
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637
Riley Hospital for Children Indianapolis Indiana 46202
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242
Norton Children's Hospital Louisville Kentucky 40202
Children's Hospital New Orleans New Orleans Louisiana 70118
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287
C S Mott Children's Hospital Ann Arbor Michigan 48109
Children's Hospital of Michigan Detroit Michigan 48201
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503
Mayo Clinic in Rochester Rochester Minnesota 55905
University of Mississippi Medical Center Jackson Mississippi 39216
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108
Washington University School of Medicine St Louis Missouri 63110
Hackensack University Medical Center Hackensack New Jersey 07601
Roswell Park Cancer Institute Buffalo New York 14263
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032
University of Rochester Rochester New York 14642
Montefiore Medical Center - Moses Campus The Bronx New York 10467
New York Medical College Valhalla New York 10595
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203
Duke University Medical Center Durham North Carolina 27710
Cleveland Clinic Foundation Cleveland Ohio 44195
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Penn State Children's Hospital Hershey Pennsylvania 17033
Medical University of South Carolina Charleston South Carolina 29425
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232
Medical City Dallas Hospital Dallas Texas 75230
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390
Cook Children's Medical Center Fort Worth Texas 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030
Methodist Children's Hospital of South Texas San Antonio Texas 78229
Primary Children's Hospital Salt Lake City Utah 84113
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792

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 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05457556, 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 Dec 21, 2025 · Synced May 8, 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 protocol, eligibility criteria, and contact information for NCT05457556 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →