Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.
Graft-versus-host disease (GVHD) is the most common long-term complication in patients who
underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on
immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory
response in around 30% of patients. There is no ideal second-line treatment for chronic
GVHD; however, numerous studies have been published with therapeutic options such as
alemtuzumab (anti-CD52) and rituximab (anti-CD20).
This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab
will be administered at low-doses to patients with refractory chronic GVHD. Clinical
response will be evaluated based on the Working Group Report 2006, published by the National
Institute of Health Consensus. Follow-up sessions will be weekly for four weeks, every two
weeks until achieve response, and finally every four weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate clinical response of alemtuzumab and rituximab combination in patients with refractory chronic GVHD based on the Working Group Report 2006.
90 days and 1 year
David Gomez-Almaguer, M.D.
Hospital Universitario Dr. Jose E. Gonzalez
Mexico: Ethics Committee