BMT CTN 0302 Randomized Phase II Trial of Four Acute GVHD Therapies

1. HCT (BM, PBSC, CB) Acute GVHD (diagnosed in past 48 hours) Yes, requiring systemic therapy No RANDOMIZATION • Prednisone, and • Etanercept , or • MMF*, or • Ontak, or • Pentostatin If progressive GVHD within 7 days, or no response within 14 days, treat with alternative secondary agent off study, follow for study endpoints Follow to Day 28(weekly scoring and steroid taper as tolerated) Study drug discontinued at Day 28, MMF continued through steroid taper, then begin MMF taper Follow to Day 270 BMT CTN 0302 Randomized Phase II Trial of Four Acute GVHD Therapies Objective Eligibility • Estimate the proportion of CR at Day 28 of therapy for newly diagnosed aGVHD for each study agent used in combination with corticosteroids • aGVHD requiring systemic therapy • No previous suppressive therapy except for maximum 48 hours prior steroids • ONTAK, Etancercept or Pentostatin within previous 7 days • Age ≥ 2 years TREATMENT SCHEMA * Patients taking MMF within 7 days of GVHD onset will be randomized to Ontak, Pentostatin or Etanercept and steroids. To view the entire protocol, go to http://www.bmtctn.net or the PDQ website at http://cancer.gov/clinicaltrials/BMTCTN-0302 This is a Phase II multi-center trial jointly sponsored by the NHLBI and NCI. Version 3.0