Status:
COMPLETED
Therapy for Chronic Cold Agglutinin Disease
Lead Sponsor:
University of Bergen
Conditions:
Cold Agglutinin Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
1\. Background Chronic cold agglutinin disease (CAD) is mediated by monoclonal cold-reactive autoantibodies that bind to erythrocyte surface antigens, causing haemagglutination and complement-mediate...
Eligibility Criteria
Inclusion
- CAD diagnosis defined by the combination of:
- Chronic haemolysis
- Cold agglutinin titre \> 64
- Positive direct antiglobulin test when performed with polyspecific antiserum, negative (or only weakly positive) with anti-IgG, and strongly positive with anti-C3d
- The presence of a clonal B-cell lymphoproliferative disorder defined by:
- Monoclonal IgMκ band by serum electrophoresis and immunofixation, and
- Lymphocyte phenotype with κ/λ-ratio \> 3.5 and CD20+,κ+ co-expression, using flowcytometric immunophenotyping of bone marrow aspirates
- Clinical symptoms requiring treatment, such as anaemia or Raynaud-like symptoms
- Informed consent
Exclusion
- An aggressive lymphoma
- Blood lymphocyte count \> 50 . 109/L
- Non-lymphatic malignant disease other than basal cell carcinoma
- Contra-indications to rituximab or fludarabine therapy
- Inability to cooperate
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00373594
Start Date
June 1 2005
End Date
May 1 2010
Last Update
June 22 2010
Active Locations (6)
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1
Haukeland University Hospital
Bergen, Norway
2
Haugesund Hospital
Haugesund, Norway
3
Ullevaal University Hospital
Oslo, Norway, 0407
4
Rikshospitalet-Radiumhospitalet University Hospital
Oslo, Norway