Phase 2 Randomized Study Comparing Post-Transplant Cyclophosphamide, Sirolimus, and Ruxolitinib Versus Cyclophosphamide, Sirolimus, and Mycophenolate Mofetil to Prevent Graft Versus Host Disease in Older Adults

What this Trial Is About

Researchers are evaluating two drug combinations to prevent graft versus host disease GVHD after stem cell transplant in patients aged 65 to 75 years with certain blood cancers including acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia. The study aims to compare how well the combinations work and their safety, focusing on acute GVHD-free survival and other important health outcomes. It is a phase 2 randomized study sponsored by M.D. Anderson Cancer Center. The study compares two treatment groups one receiving post-transplant cyclophosphamide, sirolimus, and mycophenolate mofetil taken three times daily by IV or orally, and the other receiving post-transplant cyclophosphamide, sirolimus, and ruxolitinib taken orally every 12 hours. Both treatments are given after stem cell transplant and participants receive peripheral blood stem cells from a matched or haploidentical donor. The study monitors these treatments for one year to evaluate their effects on GVHD prevention and other outcomes. Participants will be closely monitored throughout the study with assessments of adverse events, blood counts, organ function, and immune recovery. Researchers will measure several outcomes including survival without GVHD, time to blood cell recovery, incidence of relapse, and overall survival. Safety is tracked through adverse event reporting during the approximately one-year study period. Participants must provide informed consent and meet specific health criteria to join the study.

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease