Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00373594
Eligibility Criteria:
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 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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00373594
Study Brief:
Protocol Section:
NCT00373594