A PhaseI/II Double-Blind, Placebo-Controlled Study of Recombinant Human Interleukin-11 for Mucositis and Acute GVHD Prevention in Allogeneic Stem Cell Transplantation

This article presents data from a randomized double-blind pilot study of rhIL-11 administered with cyclosporine/MTX prophylaxis after cytoxan/TBI conditioning & allogeneic stem cell transplantation for hematologic malignancies. The study was designed to assess safety with stopping rules for cardiac arrhythmias & mortality. All 13 patients received bone marrow stem cells. 1 of the 3 placebo recipients died by suicide. 5 of the 10 patients who were administered IL-11 died due to transplant-related toxicity. The results indicate that IL-11 cannot be recommended in future trials. (32 refs) (SC)