Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease (LowAR)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Combination of Alemtuzumab (Anti-CD52) and Rituximab (Anti-CD20) at Low-doses in Chronic Graft Versus Host Disease Treatment After First-line Therapy Failure.|
- Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006. [ Time Frame: 30, 90 and 365 days ]Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up
- Side Effects [ Time Frame: 365 days ]Percentage of participants who experienced side effects
|Study Start Date:||October 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Alemtuzumab and rituximab
Patients with chronic GVHD after first-line therapy failure will receive Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25. THE STUDY HAVE ONLY ONE ARM.
Drug: Alemtuzumab and rituximab
Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042509
|Hematology Department of Hospital Universitario Dr Jose E Gonzalez|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Principal Investigator:||David Gomez-Almaguer, M.D.||Hospital Universitario Dr. Jose E. Gonzalez|