About this trial
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).
Eligibility criteria
Qualifiers
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%
Disqualifiers
Recipient of CD34+ selected or engineered stem cell graft
Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Cyclophosphamide
- Mycophenolate Mofetil
- Ruxolitinib
- Tacrolimus
- Tacrolimus
Treatment groups
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Incyte Corporation
Collaborator