Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (CR: complete remission, PR: partial remission, relapse rate.
1, 2, 4 and 6 months
Yes
David Gomez-Almaguer, MD
Principal Investigator
Hospital Universitario Dr. Jose E. Gonzalez
Mexico: Ethics Committee
HE08-004
NCT00749112
August 2008
August 2010
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