Clinical trialNCT05457556Active, not recruitingPhase 3Interventional

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

SponsorChildren's Oncology GroupEnrollment66Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Heather J Symons
Children's Oncology Group
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

63 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

the Children'S Hospital at Westmead
Westmead, New South Wales, Australia

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Ucsf Benioff Children'S Hospital Oakland
Oakland, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Alfred I Dupont Hospital for Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Uf Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Nemours Children'S Clinic-Jacksonville
Jacksonville, Florida, United States
Nicklaus Children'S Hospital
Miami, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Adventhealth Orlando
Orlando, Florida, United States
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Lurie Children'S Hospital-Chicago
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa/holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Norton Children'S Hospital
Louisville, Kentucky, United States
Children'S Hospital New Orleans
New Orleans, Louisiana, United States
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
C S Mott Children'S Hospital
Ann Arbor, Michigan, United States
Children'S Hospital of Michigan
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen Devos Children'S Hospital
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children'S Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States

23 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Busulfan →Cyclophosphamide →Fludarabine →Lymphocyte immune globulin, anti-thymocyte globulin →Melphalan →Methotrexate →Mycophenolate mofetil →Rituximab →Tacrolimus →Thiotepa

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Mar 2023
Primary completion: 30 Jun 2026
Completion: 7 Jul 2027
Last update posted: 30 Jul 2026
Registered enrollment: 66
Registry id: NCT05457556

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.