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).
Age 18.0 years or older at the time of enrollment
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)
Prior allogeneic transplant
Active CNS (central nervous system) involvement by malignant cells
Patients with secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes, including CMML(chronic myelomonocytic leukemia) and MDS/MPN (myelodysplastic syndromes/myeloproliferative neoplasms) syndromes; patients with secondary acute myeloid leukemia arising from myelodysplastic neoplasm are eligible.
Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Hannah Choe, MD
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Incyte Corporation
Collaborator