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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
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv4
  2. Start date changed from estimate of Mar 2025 to Feb 4, 2025 Site contact updatedv3 Show 1 more changeShow less
    • Site contact updated
  3. Trial status: Not Yet Recruiting to Recruiting Interventions: Fludarabine, Busulfan, Intensity modulated total marrow irradiation, stem cell transplantation, cyclophosphamide, mycophenolate mofetil… to Busulfan (conditioning for ALLO Transplant) (Drug), Cyclophosphamide (CTX) (Drug), Fludarabine (Fludara) (Drug), Intensity modulated total… · Site details revisedv2 Show 2 more changesShow less
    • Interventions: Fludarabine, Busulfan, Intensity modulated total marrow irradiation, stem cell transplantation, cyclophosphamide, mycophenolate mofetil… to Busulfan (conditioning for ALLO Transplant) (Drug), Cyclophosphamide (CTX) (Drug), Fludarabine (Fludara) (Drug), Intensity modulated total…
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov