Data monitoring of a placebo-controlled trial of daclizumab in acute graft-versus-host disease

This trial was undertaken to test the hypothesis that two-drug initial therapy for acute graft-versus-host disease (GVHD) would produce better control of GVHD and less exposure to corticosteroids than the standard treatment of corticosteroids alone. All participants had undergone allogeneic hematopoietic stem cell transplantation (HSCT) and developed acute GVHD. Subjects were randomized to treatment with corticosteroids plus placebo or corticosteroids plus daclizumab. The trial was continued past its first interim analysis (~30%; evaluable subjects) but was stopped after the second interim analysis (~50%; evaluable subjects) when the two-drug arm was associated with worse overall survival.