Comparing TacrolimusMethotrexateRuxolitinib to Post-Transplant CyclophosphamideTacrolimusMycophenolate Mofetil in Non-Myeloablative or Reduced Intensity Peripheral Blood Stem Cell Transplantation A Phase III Randomized Study

What this Trial Is About

Researchers are evaluating two different drug combinations to prevent graft-versus-host disease GVHD in adults undergoing non-myeloablative or reduced intensity conditioning allogeneic peripheral blood stem cell transplantation PBSC. The study compares the combination of Tacrolimus, Methotrexate, and Ruxolitinib with the combination of Post-Transplant Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. This Phase III trial aims to find better ways to improve outcomes for patients receiving stem cell transplants for certain blood cancers and disorders. Participants receive one of the study drug regimens following their transplant. The experimental groups include three different doses of the TacrolimusMethotrexateRuxolitinib combination, while the active comparator group receives Post-Transplant Cyclophosphamide with Tacrolimus and Mycophenolate Mofetil. Drugs are administered by tablet or intravenous infusion as per protocol. The trial includes a dose-finding run-in period followed by the main randomized comparison of these treatment combinations. During the study, participants are closely monitored for up to 24 months after transplant to assess outcomes such as GVHD-free survival, incidence and severity of acute and chronic GVHD, time to blood cell recovery, donor cell engraftment, graft failure, relapse or progression of disease, mortality, infections, and treatment toxicities. Patient-reported outcomes including symptom scales, work productivity, and financial impact are also collected. Safety and efficacy are evaluated through regular clinical assessments and laboratory tests throughout the follow-up period.

A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)