Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Phase 2

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura; Anemia, Hemolytic, Autoimmune
• Interventions: Drug: Alemtuzumab, Rituximab

• Registration Number: NCT00749112
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 Description

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-27
• Last Update Posted: 2010-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Age: > or = 16 years
• Weight: more than 40 Kg
• Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant
• Idiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to treatment, in relapse or steroids dependant

Exclusion Criteria

• Current viral or bacterial infection.
• Positive serology for HIV, HCV, HBV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Alemtuzumab, Rituximab	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (CR: complete remission, PR: partial remission, relapse rate.	1, 2, 4 and 6 months

Trial Locations

Locations (1)

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer; 🇲🇽 Monterrey, Nuevo Leon, Mexico