Therapy for Chronic Cold Agglutinin Disease
This study has been completed.
Sponsor:
University of Bergen
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00373594
First received: September 7, 2006
Last updated: June 18, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cold Agglutinin Disease |
Drug: Rituximab Drug: Fludarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine. |
Resource links provided by NLM:
Further study details as provided by University of Bergen:
Primary Outcome Measures:
- Hemoglobin level
- Hemolysis
- Circulatory symptoms
- Serum monoclonal immunoglobulin level
- Changes in bone marrow histology
- Adverse effects
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373594
Locations
| Norway | |
| Haukeland University Hospital | |
| Bergen, Norway | |
| Haugesund Hospital | |
| Haugesund, Norway | |
| Rikshospitalet-Radiumhospitalet University Hospital | |
| Oslo, Norway | |
| Ullevaal University Hospital | |
| Oslo, Norway, 0407 | |
| Sykehuset i Vestfold | |
| Tonsberg, Norway | |
| Russian Federation | |
| BMT Clinic, St Petersburg Pavlov State Medical University | |
| St Petersburg, Russian Federation, 197089 | |
Sponsors and Collaborators
University of Bergen
Investigators
| Study Chair: | Sigbjorn Berentsen, MD, PhD | Haugesund Hospital and University of Bergen |
| Study Chair: | Geir E Tjonnfjord, MD, PhD | Rikshospitalet-Radiumhospitalet University Hospital, Oslo |
| Study Chair: | Elling Ulvestad, MD, PhD | The Gade Institute, Haukeland University Hospital, Bergen |
More Information
Additional Information:
Publications:
1. Berentsen S, Ulvestad E, Langholm R, Beiske K, Hjorth-Hansen H, Ghanima W et al. Primary chronic cold agglutinin disease: a population based clinical study of 86 patients. Haematologica 2006;91:460-6. 2. Ulvestad E, Berentsen S, Bo K, Shammas FV. Clinical immunology of chronic cold agglutinin disease. Eur J Haematol 1999;63:259-66. 3. Ulvestad E, Berentsen S, Mollnes TE. Acute phase haemolysis in chronic cold agglutinin disease. Scand J Immunol 2001;54:239-42. 4.Berentsen S, Ulvestad E, Gjertsen BT, Hjorth-Hansen H, Langholm R, Knutsen H et al. Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients. Blood 2004;103:2925-8.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. S. Berentsen, MD, PhD, Haugesund Hospital |
| ClinicalTrials.gov Identifier: | NCT00373594 History of Changes |
| Other Study ID Numbers: | 911238 |
| Study First Received: | September 7, 2006 |
| Last Updated: | June 18, 2010 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by University of Bergen:
|
Cold agglutinin disease Hemolytic Anemia Lymphoproliferative disease |
Monoclonal antibodies Rituximab Fludarabine |
Additional relevant MeSH terms:
|
Anemia, Hemolytic, Autoimmune Anemia, Hemolytic Anemia Hematologic Diseases Autoimmune Diseases Immune System Diseases Agglutinins Cold agglutinins Fludarabine monophosphate Rituximab Fludarabine |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Hemagglutinins Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013