Status:
COMPLETED
Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Idiopathic Thrombocytopenic Purpura
Anemia, Hemolytic, Autoimmune
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
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 ster...
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 s...
Eligibility Criteria
Inclusion
- 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
- Current viral or bacterial infection.
- Positive serology for HIV, HCV, HBV.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00749112
Start Date
August 1 2008
End Date
August 1 2010
Last Update
August 30 2010
Active Locations (1)
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1
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo León, Mexico, 64460