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

> **NCT05457556** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Children's Oncology Group** · enrollment: 435 (estimated)

## Conditions studied

- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Mixed Phenotype Acute Leukemia
- Myelodysplastic Syndrome

## Interventions

- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Bone Marrow Aspiration
- **DRUG:** Busulfan
- **DRUG:** Cyclophosphamide
- **PROCEDURE:** Echocardiography Test
- **DRUG:** Fludarabine
- **PROCEDURE:** Haploidentical Hematopoietic Cell Transplantation
- **BIOLOGICAL:** Lapine T-Lymphocyte Immune Globulin
- **PROCEDURE:** Lumbar Puncture
- **PROCEDURE:** Matched Unrelated Donor Hematopoietic Cell Transplantation
- **DRUG:** Melphalan
- **DRUG:** Methotrexate
- **PROCEDURE:** Multigated Acquisition Scan
- **DRUG:** Mycophenolate Mofetil
- **PROCEDURE:** Myeloablative Conditioning
- **OTHER:** Quality-of-Life Assessment
- **OTHER:** Questionnaire Administration
- **BIOLOGICAL:** Rituximab
- **PROCEDURE:** T-Cell Depletion Therapy
- **DRUG:** Tacrolimus

## Key facts

- **NCT ID:** NCT05457556
- **Lead sponsor:** Children's Oncology Group
- **Sponsor class:** NETWORK
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-03-15
- **Primary completion:** 2026-06-30
- **Final completion:** 2026-06-30
- **Target enrollment:** 435 (ESTIMATED)
- **Last updated:** 2025-12-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05457556

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05457556, "Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome". Retrieved via AI Analytics 2026-07-06 from https://api.ai-analytics.org/clinical/NCT05457556. Licensed CC0.

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