A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Incyte Corporation
Summary
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18.0 years or older at the time of enrollment. * Participants undergoing allogeneic HCT for one of the following indications: * Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed. * 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). Therapy related m…
Interventions
- DrugTacrolimus (Tac)
Tablet or intravenously (IV)
- DrugMethotrexate (MTX)
Intravenously (IV)
- DrugRuxolitinib (Rux)
Tablet
- DrugCyclophosphamide
Intravenously (IV)
- DrugMycophenolate mofetil (MMF)
Tablet or intravenously (IV)
Locations (30)
- Stanford Cancer CenterPalo Alto, California
- University of California San FranciscoSan Francisco, California
- University of MiamiMiami, Florida
- Moffitt Cancer CenterTampa, Florida
- Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia
- Indiana University Cancer CenterIndianapolis, Indiana