A Phase II Trial of De-escalated PTCy and Ruxolitinib for GVHD Prophylaxis in Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT
This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.
• History of hematologic malignancy.
• Must be in remission:
‣ Acute Leukemia, chronic leukemia, or myelodysplasia/myeloproliferative neoplasm (excluding primary myelofibrosis): No circulating blasts and \<5% blasts in the bone marrow.
⁃ Hodgkin and non-Hodgkin lymphomas: Chemo-sensitive disease at time of transplant
• Patients must have a related or unrelated peripheral blood stem cell donor that is an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donors must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.
• Planned reduced intensity conditioning therapy with fludarabine/melphalan, with total dose of melphalan of 100-140 mg/m\^2 IV or fludarabine/busulfan with total dose of busulfan of 6.4 mg/kg IV.
• Karnofsky Performance Scale of 60 or greater.
• Male participants must agree to abstinence or to use of barrier contraception during the entire study period.
• Female participants of childbearing potential will require a negative pregnancy test and should agree to practice two effective methods of contraception during the entire study period.
• Ability to understand a written informed consent document, and the willingness to sign it.