Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Objective response rate (CR: complete remission, PR: partial remission, relapse rate.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
Intervention: Alemtuzumab, Rituximab (Drug)
Outcomes
Primary Outcomes
Objective response rate (CR: complete remission, PR: partial remission, relapse rate.
Time Frame: 1, 2, 4 and 6 months
Secondary Outcomes
No secondary outcomes reported