Phase II Study of Intensity Modulated Total Marrow Irradiation Added to Chemotherapy for Haploidentical Stem Cell Transplant in Adults with Acute Leukemia or Myelodysplastic Syndrome

What this Trial Is About

Researchers are studying patients with acute leukemia and myelodysplastic syndrome MDS to see if adding a targeted form of radiation called Intensity Modulated Total Marrow Irradiation IM-TMI to the usual chemotherapy-based conditioning regimen before haploidentical stem cell transplant can better kill cancer cells in the bone marrow and lower the risk of disease return. This is a phase II clinical trial focusing on a specific transplant preparation approach. Participants will receive a standard conditioning treatment including chemotherapy drugs fludarabine and cyclophosphamide, along with total body irradiation, before receiving a stem cell transplant from a partially matched donor. The IM-TMI radiation is given as a small dose twice daily on days -3 and -2 before transplant, combined with other drugs to prevent graft-versus-host disease after transplant. The full treatment spans several days leading up to and following the transplant. During the study, participants will be closely monitored with assessments of their survival without graft-versus-host disease or relapse at one year as the main outcome. Additional measurements include rates of toxic side effects, success of stem cell engraftment, donor cell presence, overall survival, and disease progression. Follow-up visits and tests will continue for at least one year after the transplant to track these outcomes and ensure safety throughout the process.

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)