Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (NCT05457556)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 6 Months to 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (63 Sites)
Showing the first 25 of 63 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- Phoenix Childrens Hospital — Phoenix, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- City of Hope Comprehensive Cancer Center — Duarte, California
- Loma Linda University Medical Center — Loma Linda, California
- Children's Hospital Los Angeles — Los Angeles, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Yale University — New Haven, Connecticut
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- Children's National Medical Center — Washington D.C., District of Columbia
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- Nicklaus Children's Hospital — Miami, Florida
- AdventHealth Orlando — Orlando, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Lurie Children's Hospital-Chicago — Chicago, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- Riley Hospital for Children — Indianapolis, Indiana
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa
- Norton Children's Hospital — Louisville, Kentucky
- Children's Hospital New Orleans — New Orleans, Louisiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.