Therapy for Chronic Cold Agglutinin Disease
- Sponsor
- University of Bergen
- Study ID
- NCT00373594
- Phase
- PHASE2
- Status
- Completed
Conditions
- Cold Agglutinin Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUG
- Fludarabine — DRUG
Study Details
Chronic cold agglutinin disease (CAD) is a type of autoimmune hemolytic anemia (anemia due to destruction of red blood cells by abnormal antibodies). Almost all patients also suffer from cold-induced disturbances of blood circulation. The purpose of this study is to assess the efficacy and safety of combination therapy with rituximab (an antibody against B lymphocytes) and fludarabine (a cytotoxic drug) for CAD. Another aim is to try to assess whether these agents in combination are better than single agent therapy with rituximab.
Key Dates
- Start date
- Jun 30, 2005
- Status verified
- Jun 2010
- Primary completion
- Apr 30, 2010
- Completion
- May 31, 2010
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Hemoglobin level