Study Comparing Post-Transplant Cyclophosphamide Plus Calcineurin Inhibitors Versus Methotrexate Plus Calcineurin Inhibitors for Preventing GVHD in Acute Leukemia Patients Aged 14 to 65

What this Trial Is About

Researchers are evaluating two different approaches to prevent graft-versus-host disease GVHD in patients with acute leukemia undergoing allogeneic hematopoietic stem cell transplantation allo-HCT. This phase 3 randomized clinical trial compares the current standard GVHD prevention regimen using methotrexate and calcineurin inhibitors to a newer strategy using post-transplant cyclophosphamide combined with calcineurin inhibitors. The study includes patients aged 14 to 65 with acute myeloid leukemia AML or acute lymphoblastic leukemia ALL in remission who have a matched related donor for stem cell transplantation. Participants are randomly assigned to one of two treatment groups. The experimental group receives a myeloablative conditioning regimen followed by matched related donor peripheral blood stem cell transplant, with cyclophosphamide given intravenously at 50 mgkgday on days 3 and 5 post-transplant, along with oral tacrolimus or another calcineurin inhibitor. The standard care group receives a similar transplant and conditioning regimen but with methotrexate given on days 1, 3, and 6 alongside calcineurin inhibitors for GVHD prevention. Both groups use myeloablative conditioning tailored to leukemia type, such as IV BusulfanFludarabine for AML or VP16TBI for ALL. During the study, participants are monitored for graft-versus-host disease occurrence, survival without relapse, and other health outcomes for at least one year post-transplant. Researchers assess acute GVHD within 100 days and chronic GVHD within one year after transplant. Evaluations include cardiac, pulmonary, liver, and kidney function tests at baseline, as well as ongoing clinical monitoring. The study measures GVHD-free and relapse-free survival at one year to compare the effectiveness of the two prophylaxis strategies. The total duration of participation varies based on transplant and follow-up schedules.

Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients