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ACTIVE NOT RECRUITING Phase 3

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

NCT05457556 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 435 participants
Start Date 2023-03-15
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05457556

The ClinicalTrials.gov registry entry for NCT05457556 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05457556 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05457556?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial