NCT00749112

Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Thrombocytopenic Purpura
• Anemia, Hemolytic, Autoimmune

Interventions

Type	Name	Description
DRUG	Alemtuzumab, Rituximab	Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-09-09
• Last updated: 2010-08-30

Locations

1 site across 1 country: Mexico