Status:
TERMINATED
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
Lead Sponsor:
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsors:
Bayer
Conditions:
Autoimmune Cytopenias
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP), autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will respond to conve...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of the following autoimmune cytopenias:
- immune thromobocytopenia purpura (ITP) autoimmune hemolytic anemia (AIHA) autoimmune neutropenia (AIN) pure red cell aplasia (PRCA) and
- Patients must have refractory disease according to the following criteria
- not respond to steroids or
- need prednisolone more than 15 mg/d for maintenance therapy
- Complete work up for baseline evaluation and measurement
- Age \> 18 years
- Patient's free written inform consent
Exclusion
- Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab
- Patients with poor performance status (ECOG criteria of 3-4)
- Serologic evidence of human immunodeficiency virus exposure
- Patients with active uncontrolled infection. Patients that are HIV positive or test positive on HBs or HCV antigens.
- Pregnant or lactating women
- Serious medical or psychiatric illness which prevent informed consent
- Patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted)
- Patients with active malignancies
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00472433
Start Date
March 1 2007
End Date
May 1 2009
Last Update
June 22 2009
Active Locations (1)
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1
Phramongkutklao Hospital
Bangkok, Thailand, 10400