Clinical Trial

Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

Study acronym: BMT-13
Recruiting Phase 2
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Summary
The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-28; most recent amendment 2026-06-23.
Status change: Not Yet Recruiting → Recruiting 2025-01-31
Trial Details
NCT Number NCT06802315
Lead Sponsor University of Illinois at Chicago
Conditions Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory, Chronic Myeloid Leukemia - Accelerated Phase, Myelodysplastic Syndromes
Enrollment 38 participants
Start Date 2025-02-04
Primary Completion 2030-03 (estimated)
Study Completion 2032-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-26