Clinical Trial: Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome: 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


Original Primary Outcome: Evaluate clinical response of low-doses alemtuzumab and rituximab in patients with refractory chronic GVHD based on the Working Group Report 2006. [ Time Frame: 90 days and 1 year ]

Current Secondary Outcome: Side Effects [ Time Frame: 365 days ]

Percentage of participants who experienced side effects


Original Secondary Outcome:

  • Measure side effects of low-doses alemtuzumab and rituximab treatment by clinical evaluation. [ Time Frame: 90 days and 1 year ]
  • Measure time response achieved after low-doses alemtuzumab and rituximab treatment by clinical evaluation. [ Time Frame: 90 days and 1 year ]


Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: January 4, 2010
Date Started: October 2009
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016