BMT-13
A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine/Busulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS
Sponsor study identifier
interventional
38
1 country
1
Study Start
February 4, 2025
Actual (reported)Primary Completion
March 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2025
Actual (reported)January 31, 2025
Actual (reported)February 4, 2025
Actual (reported)March 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
GVHD-Free Relapse-Free Survival after Stem Cell Transplant
The 1-year GVHD- free relapse-free survival after HSCT (hematopoietic stem cell transplantation) conditioned with a 9Gy TMI in combination with FluBu4 and PTCY in patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), Myelodysplastic Syndrome (MDS) at high risk of relapse.
1 Year Post-Stem Cell Transplant
Overall Survival
2 Years Post-Stem Cell Transplant
Time To Engraftment
30 Days Post-Stem Cell Transplant
Days -5 through -2: Fludarabine 40 mg/m2 IVPB daily and Busulfan targeting AUC 4800μM/min daily Day -3 through -1: Intensity modulated total marrow irradiation (9Gy fractionated) Day 0: Infuse peripheral blood mobilized stem cells Days +3 and +4: Cyclophosphamide 50 mg/kg/day Day 5: Mycophenolate mofetil and Tacrolimus (dose adjustment dependent on trough level) Day 30: Follow up Day 60: Follow up Day 90: Follow up Day 180: Follow up 1. year: Follow up 2. year: Follow up
This study will determine the safety of the combination of Total Marrow Irradiation (TMI) and Post-Transplant Cyclophosphamide using a myeloablative fludarabine and iv targeted busulfan (Flu/Bu4) conditioning regimen.
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Matias Sanchez, MD
University of Illinois at Chicago
First Submitted
January 28, 2025
First Posted
January 31, 2025
Study Start
February 4, 2025
Actual (reported)Primary Completion
March 2030
EstimatedAdverse Events
30 Days Post-Stem Cell Transplant
Adverse Events
60 Days Post-Stem Cell Transplant
Adverse Events
90 Days Post-Stem Cell Transplant
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 26, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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