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NCT05457556 · ClinicalTrials.gov registry record · Phase 3
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
A Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
- 20
- Study locations
NCT05457556: Active Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Children's Oncology Group.
NCT05457556 is a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 435 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (282% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457556, a Phase 3 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
We will estimate the cumulative incidence of severe GVHD at 1-year post-HCT and corresponding 95% confidence interval among enrolled and eligible patients randomly assigned to either HAPLO or MUD arms who actually undergo HCT.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- DRUG Busulfan
- PROCEDURE Echocardiography Test
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital Oakland - Oakland
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Nemours Children's Clinic-Jacksonville - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Nicklaus Children's Hospital - Miami
- AdventHealth Orlando - Orlando
- Johns Hopkins All Children's Hospital - St. Petersburg
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale University - New Haven
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT05457556 still lists
NCT05457556 is an interventional study that assigns participants to a tested intervention. The registered 435 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (282% higher).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05457556 names 20 study sites across 10 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05457556 about?
NCT05457556 is a clinical study titled "Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome". 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 ...
What is the current status of trial NCT05457556?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2023-03-15. Estimated completion is 2026-06-30.
What conditions does trial NCT05457556 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia.
What interventions are being tested in trial NCT05457556?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Busulfan (DRUG), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT05457556?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457556 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05457556's enrollment target sits among peer trials
435 12th of 306 higher than 295 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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