Phase II Evaluation of Intensity-Modulated Total Marrow Irradiation and Chemotherapy Conditioning with Post-Transplant Cyclophosphamide for High-Risk Leukemia and Myelodysplastic Syndrome in Allogeneic Stem Cell Transplant

What this Trial Is About

This research aims to evaluate a treatment approach for patients with high-risk acute myeloid leukemia AML, chronic myeloid leukemia CML, and myelodysplastic syndrome MDS who are undergoing allogeneic hematopoietic stem cell transplantation HSCT. The study is a Phase II clinical trial investigating intensity-modulated total marrow irradiation TMI combined with standard myeloablative fludarabine and busulfan conditioning. The focus is on patients with either fully HLA-matched or partially mismatched donors to improve transplant outcomes and manage graft-versus-host disease GVHD. Participants receive fludarabine intravenously and busulfan chemotherapy from five days to two days before stem cell infusion. They also undergo fractionated TMI at a total dose of 9 Gray over three days prior to the transplant. On the day of transplant, stem cells are infused, followed by GVHD prevention treatment including cyclophosphamide given on days 3 and 4, along with tacrolimus and mycophenolate mofetil starting on day 5. The study monitors safety and effects of this combined conditioning and GVHD prophylaxis regimen. During the study, participants are evaluated at multiple time points including days 30, 60, 90, 180, 365, and two years after the transplant. Researchers collect data on survival, time to engraftment, incidence of acute and chronic GVHD, adverse events, and transplant-related mortality. The primary outcome is GVHD-free relapse-free survival at one year post-transplant. The study spans up to two years of follow-up to assess long-term outcomes and safety for participants receiving this treatment combination.

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)