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Allogeneic hematopoietic stem-cell transplantation (AHSCT) is often complicated by acute graft-versus-host disease (GVHD) and is generally treated with corticosteroids. Because these agents induce durable remissions in fewer than half of patients with GVHD, they are often combined with immunosuppressive agents. In a previous phase II study, the immunosuppressor mycophenolate mofetil (MMF), when combined with corticosteroids, appeared to improve disease-free interval and overall survival (Blood 2009; 114:511).
To confirm these preliminary results, investigators conducted a phase III trial involving 235 eligible adult and pediatric AHSCT recipients with newly diagnosed acute GVHD. Patients were randomized to receive prednisone with either MMF …