Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease (LowAR)
Recruitment status was Recruiting
The purpose of this study is to determine whether low-doses alemtuzumab and rituximab combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after first-line therapy failure.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.|
- Evaluate clinical response of alemtuzumab and rituximab combination in patients with refractory chronic GVHD based on the Working Group Report 2006. [ Time Frame: 90 days and 1 year ] [ Designated as safety issue: Yes ]
- Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation. [ Time Frame: 90 days and 1 year ] [ Designated as safety issue: Yes ]
- Measuring the response time achieved with the combination of alemtuzumab and rituximab through clinical evaluation. [ Time Frame: 90 days and 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Patients with chronic GVHD
Patients with chronic GVHD after first-line therapy failure.
Drug: Alemtuzumab and Rituximab combination
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.
|Contact: Miguel A Gomez-Guijosa, M.D.||+52 81 83 48 61 firstname.lastname@example.org|
|Contact: David Gomez-Almaguer, M.D.||+52 81 83 48 85 email@example.com|
|Hematology Department of Hospital Universitario Dr Jose E Gonzalez||Recruiting|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Contact: Miguel A Gomez-Guijosa, M.D. +52 81 83 48 61 36 firstname.lastname@example.org|
|Contact: David Gomez-Almaguer, M.D. +52 81 83 48 85 10 email@example.com|
|Principal Investigator: David Gomez-Almaguer, M.D.|
|Sub-Investigator: Cesar H Gutierrez-Aguirre, M.D.|
|Sub-Investigator: Miguel A Gomez-Guijosa, M.D.|
|Sub-Investigator: Manuel Solano-Genesta, M.D.|
|Sub-Investigator: Olga G Cantu-Rodriguez, M.D.|
|Principal Investigator:||David Gomez-Almaguer, M.D.||Hospital Universitario Dr. Jose E. Gonzalez|