Intensity Modulated Total Marrow Irradiation with Fludarabine/Busulfan and Post-Transplant Cyclophosphamide for HLA-Matched and Partially Mismatched Allogeneic Transplant in High-Risk AML, CML, and MDS

What this Trial Is About

This research aims to evaluate a new conditioning approach for adult patients with high-risk blood cancers including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and myelodysplastic syndromes (MDS). It is a Phase II clinical trial studying the combination of intensity-modulated total marrow irradiation (TMI) with chemotherapy before allogeneic hematopoietic stem cell transplant (HSCT). The goal is to assess the impact on graft-versus-host disease (GVHD)-free relapse-free survival after transplant. Participants will receive fludarabine chemotherapy intravenously and targeted busulfan from five to two days before stem cell infusion. Intensity-modulated total marrow irradiation is given in divided doses on the three days before transplant. On the day of transplant, the stem cells are infused. To prevent GVHD, cyclophosphamide is given on days three and four after transplant, followed by mycophenolate mofetil and tacrolimus starting on day five. Follow-up visits are scheduled at multiple timepoints up to two years post-transplant. During the study, researchers will collect data on safety, adverse events, GVHD incidence, transplant-related mortality, and survival outcomes at various points from 30 days to two years after transplant. Participants will have regular assessments as part of standard post-transplant care, with data collected at days 30, 60, 90, 180, one year, and two years. This detailed monitoring helps evaluate how well the treatment regimen works and its effects on patients over time.

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)