Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Trial Parameters
Brief Summary
This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).
Eligibility Criteria
Inclusion Criteria: * Age 18.0 years or older at the time of enrollment * Patients undergoing allogeneic hematopoietic cell transplantation for one of the following indications: * Acute leukemia with no circulating blasts and with less than 5% blasts in the bone marrow * Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \<5% versus 5-10% blasts in this disease). * Planned myeloablative (MAC) conditioning regimen (see eligible regimens in Section 9.2) * Patients must have a related or unrelated peripheral blood stem cell donor as follows: * Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. * Unrelated donor must be an 8/8 match at HLA-A, -