The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
Patients ≥18- years-old at time of consent
Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
Karnofsky score ≥ 70%
Recipient of CD34+ selected or engineered stem cell graft
Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
Parallel
Cyclophosphamide
DrugAn intermediate dose (medium dose) of Post-transplant Cyclophosphamide
Cyclophosphamide
DrugA full dose of Post-transplant Cyclophosphamide
Mycophenolate Mofetil
DrugDay +5 to +35
Ruxolitinib
Drugtwice a day
Tacrolimus
DrugDay +5, taper per SoC
Tacrolimus
DrugDay +5, taper initiation within 2 weeks of starting Ruxolitinib
assess cGVHD-free survival
Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.
incidence of grade 2-4 infections.
Grade 2-4 infections by CTCAE v5 either clinically or microbiologically will be assessed throughout the study until day +365. Causality and relationship with ruxolitinib will be determined.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Incyte Corporation
Collaborator
