Clinical Trial: Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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

Official Title: Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Brief Summary: The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Detailed Summary: Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Current Primary Outcome: Objective response rate (CR: complete remission, PR: partial remission, relapse rate. [ Time Frame: 1, 2, 4 and 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitario Dr. Jose E. Gonzalez

Dates:
Date Received: September 8, 2008
Date Started: August 2008
Date Completion:
Last Updated: August 27, 2010
Last Verified: August 2010