Clinical Trials | Phase II Randomized Trial Assessing Safety and Efficacy of Combination Reduced-dose Post-Transplant Cyclophosphamide, Tacrolimus, MMF, and Ruxolitinib as Graft-versus-Host Disease Prophylaxis in Adults with Hematologic Malignancies undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Hematologic Malignancies undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation. The purpose of this study is to increase access to transplant by using mismatched unrelated donors. Preliminary data suggests that a mismatched transplant can be done safely with the use of post transplant cyclophosphamide. In this study, we use a combination of reduced-dose post-transplant cyclophosphamide (PTCy), tacrolimus, mycophenolate mofetil (MMF) and ruxolitinib following mismatched unrelated donor (MMUD) peripheral blood stem cell (PBSC) hematopoietic cell transplantation (HCT). Study treatment consists of either myeloablative or reduced intensity conditioning regimen, MMUD PBSC transplant, and GVHD prophylaxis. This study will evaluate the use of reduced-dose post-transplant PTCy (25 mg/kg on Days 3 and 4 post HCT) in combination with tacrolimus, MMF and ruxolitinib compared to control post-transplant PTCy (50 mg/kg on days 3 and 4 post HCT) in combination with tacrolimus and MMF. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. Enrollment is expected to occur over a 2-year period for randomization phase, with an additional 1 year of follow-up. Subject participation on this study will be approximately 13 months. Additional information found here: [TBD] For questions, contact: [email protected]