This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate/calcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.
Patients with Acute Leukemias (AML, ALL) in morphologic complete remission with or without hematologic recovery
Patients must have a fully matched (8/8) related donor willing to donate peripheral blood stem cells and must meet institutional criteria for donation
Planned Myeloablative conditioning regimen
Cardiac function: ejection fraction at rest ≥ 50% by MUGA or TTE
Karnofsky or Lansky Performance Score < 70%.
Active disease
Patients with uncontrolled bacterial, viral, or fungal infections
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
King Faisal Specialist Hospital & Research Center
Lead sponsor