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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00373594 |
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Date of registration:
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07/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapy for Chronic Cold Agglutinin Disease
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Scientific title:
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Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine. |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00373594 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Norway
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Russian Federation
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Contacts
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Name:
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Elling Ulvestad, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Gade Institute, Haukeland University Hospital, Bergen |
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Name:
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Sigbjorn Berentsen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haugesund Hospital and University of Bergen |
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Name:
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Geir E Tjonnfjord, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rikshospitalet-Radiumhospitalet University Hospital, Oslo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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
2. The presence of a clonal B-cell lymphoproliferative disorder defined by:
- Monoclonal IgM? band by serum electrophoresis and immunofixation, and
- Lymphocyte phenotype with ?/?-ratio > 3.5 and CD20+,?+ co-expression, using
flowcytometric immunophenotyping of bone marrow aspirates
3. Clinical symptoms requiring treatment, such as anaemia or Raynaud-like symptoms
4. Informed consent
Exclusion Criteria:
1. An aggressive lymphoma
2. Blood lymphocyte count > 50 . 109/L
3. Non-lymphatic malignant disease other than basal cell carcinoma
4. Contra-indications to rituximab or fludarabine therapy
5. Inability to cooperate
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cold Agglutinin Disease
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Intervention(s)
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Drug: Rituximab
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Drug: Fludarabine
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Primary Outcome(s)
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Adverse effects
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Hemoglobin level
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Serum monoclonal immunoglobulin level
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Circulatory symptoms
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Hemolysis
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Changes in bone marrow histology
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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