Status:
UNKNOWN
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Gruppo Italiano Studio Linfomi
Conditions:
Chronic Lymphocytic Leukemia Stage A(0)
Chronic Lymphocytic Leukemia Stage A(I)
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guideline...
Detailed Description
Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registrati...
Eligibility Criteria
Inclusion
- Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
- Age \> 18 years and \< 70 years.
- Eastern Cooperative Oncology Group (ECOG)\<=2.
- Binet stage A.
- Diagnosis performed within 12 months before inclusion in the study.
- Patients who do not necessitate therapy by NCI guidelines (watch and wait policy).
- Shipment of peripheral blood sample to centralized laboratory for biological assessment.
- Clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
- Written informed consent.
Exclusion
- Patients with CLL whose diagnosis exceed 12 months before registration.
- Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
- Clinical Binet stage B or C.
- Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
- Age \> 70 years.
- Without a written informed consent.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00917540
Start Date
February 1 2007
End Date
April 1 2013
Last Update
April 9 2013
Active Locations (1)
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1
GISL Trial Office
Modena, Italy, 41100