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A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
This encompasses two studies: 1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/ tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.
The primary objective of the trial is to compare 1 year GVHD-free, relapse-free survival (GRFS) between the two GVHD prophylaxis regimens. An event for this time-to-event outcome is defined as grade III-IV aGVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause. Secondary objectives are to describe for each treatment arm rates of grade II-IV and III-IV aGVHD, rates of Minnesota high risk aGVHD, chronic GVHD, immunosuppression-free survival at 1 year, hematologic recovery (neutrophil and platelet), donor cell engraftment, disease relapse or progression, transplant-related mortality, rates of grade 3+ toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidence of grade 2-3 infections, immune reconstitution, and overall survival.
Cellcept (Mycophenolate Mofetil); FK506 (Tacrolimus); Mycophenolate Mofetil (); Tacrolimus (); cyclophosphamide (); cytoxan (cyclophosphamide); methotrexate ()