Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease (LowAR)
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|ClinicalTrials.gov Identifier: NCT01042509|
Recruitment Status : Completed
First Posted : January 5, 2010
Results First Posted : February 1, 2017
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Graft vs Host Disease||Drug: Alemtuzumab and rituximab||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||January 2012|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|