Testing Bendamustine With or Without Cyclophosphamide to Prevent Graft-Versus-Host Disease in Adults Undergoing Stem Cell Transplant for Blood Cancers

What this Trial Is About

Researchers are evaluating bendamustine with or without cyclophosphamide to prevent graft-versus-host disease GVHD in patients undergoing stem cell transplantation for blood cancers. This phase III trial aims to find the safest dose and study side effects, survival rates, and immune recovery after transplant. Chemotherapy and total body irradiation prepare the body for new stem cells, while post-transplant drugs help prevent donor cells from attacking the patient. Participants are assigned to one of two treatment schedules. Both include chemotherapy drugs fludarabine and melphalan or bendamustine, total body irradiation, and stem cell transplant. On day 3 and 4 after transplant, patients receive cyclophosphamide, bendamustine, or both, followed by immunosuppressive medications tacrolimus and mycophenolate mofetil for several months. Filgrastim is given daily until blood counts normalize. Some patients with certain blood cancers also receive rituximab at specific times before and after transplant. During the study, participants are closely monitored weekly for 3 months, then every 3 months during the first year, and every 6 months in the second year. Assessments include safety, toxicity, GVHD symptoms, survival, relapse, and immune system recovery. The main outcomes focus on finding the maximum tolerated dose and tracking adverse events up to two years after treatment. This trial is led by M.D. Anderson Cancer Center and runs through July 2027.

Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant