Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Study ID
- NCT00749112
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Anemia, Hemolytic, Autoimmune
- Idiopathic Thrombocytopenic Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Alemtuzumab, Rituximab — DRUGAlemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.
Study Details
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.
Key Dates
- Start date
- Aug 31, 2008
- Status verified
- Aug 2010
- Primary completion
- Aug 31, 2010
- Completion
- Aug 31, 2010
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: A
Primary Outcome Measure
Objective response rate (CR: complete remission, PR: partial remission, relapse rate. [ Time Frame: 1, 2, 4 and 6 months ]