Campath-1H + FK506 and Methylprednisolone for GVHD

Overview

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

OBJECTIVES: Primary * Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation. Secondary * Determine the best response at 4 and 12 weeks in patients treated with this regimen. * Determine 6-month survival of patients treated with this regimen. * Determine the rate of infectious complications in patients treated with this regimen. * Determine rate of chronic GVHD in patients treated with this regimen. OUTLINE: This is an open-label, single-blind, multicenter study. Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection. After completion of study treatment, patients are followed at 2 and 4 weeks. PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.

Conditions