Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

Inclusion Criteria: Prior allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells, or cord blood De novo acute GVHD diagnosed within 48 hours prior to enrollment; biopsy confirmation of GVHD is strongly recommended but not required; enrollment should not be delayed awaiting biopsy or pathology results; the patient must have had no previous systemic immune suppressive therapy given for treatment of acute GVHD except for a maximum 48 hours of prior corticosteroid therapy (at least 1 mg/kg/day methylprednisolone) Patients that have undergone a scheduled donor lymphocyte infusion (DLI) as part of their original transplant therapy plan Absolute neutrophil count (ANC) greater than 500/µL Clinical status at enrollment to allow tapering of steroids to not less than 1 mg/kg/day methylprednisolone (1.4 mg/kg/day prednisone) at Day 28 of therapy (e.g., persisting malignant disease suggesting the need for accelerated taper of immunosuppression) Estimated creatinine clearance greater than 30 mL/minute Assent and educational materials provided to, and reviewed with, patients under the age of 18 Exclusion Criteria: ONTAK, pentostatin, or etanercept given within 7 days of enrollment Active uncontrolled infection Patients that have undergone an unscheduled DLI, or DLI that was not part of their original transplant therapy plan If any prior steroid therapy (for indication other than GVHD), treatment at doses of at least 0.5 mg/kg/day methylprednisolone within 7 days prior to onset of GVHD Patients unlikely to be available at the transplant center on Day 28 and 56 of therapy A clinical syndrome resembling de novo chronic GVHD developing at any time after allotransplantation (see Chapter 2 of the BMT CTN Manual of Procedures for details of de novo chronic GVHD) Other investigational therapeutics for GVHD within 30 days, including agents used for GVHD prophylaxis Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study Adults unable to provide informed consent Patients with a history of intolerance to any of the study drugs