Abstract

AbstractBackground. Chronic graft-versus-host disease is a common late complication of allogeneic hematopoietic stem cell transplantation. Corticosteroids are the standard initial treatment. A second-line treatment is not well defined. We evaluated the effectiveness and safety of low doses of alemtuzumab plus low doses of rituximab as treatment steroid-refractory chronic graft-versus-host disease. Design and methods. Ten men and 5 women were prospectively included. All patients received one cycle of subcutaneous Alemtuzumab 10 mg/day/3 days and intravenous Rituximab 100 mg on days +4, +11, +18 and +25. The therapeutic response was measured on days +30, +90 and +365 of the protocolResults. The median age was 41 years. The main site involved was the oral mucosa (86.7%) followed by the eyes (66.7%), liver (60%), skin (53%), lungs (13.3%) and intestinal tract (6.7%). The overall response was 100% at +30-day evaluation; 10 patients (67%) had partial remission, and 5 patients (33%) had complete remission. At +90-day evaluation, 7 (50%) patients had partial remission, 4 (28%) had complete remission; 3 (21%) had chronic graft-versus-host disease relapsed and 1 patient do not reached evaluation. Currently, 5 patients have reached the +365-day follow-up evaluation, 2 (40%) had partial remission, 2 had complete remission and 1 showed chronic graft-versus-host disease progression. The adverse effects were mainly infectious in 67% of patients, quickly solved in all cases, except one patient who died from pneumonia. Conclusions. This combination therapy appears to be an efficacious and safe treatment for steroid-refractory chronic graft-versus-host disease. Longer follow-up is necessary in this study in order to determine the durability of response and survival. (ClinicalTrials.gov: NCT01042509).