Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia

• Conditions: Chronic Lymphocytic Leukemia Stage A(I); Chronic Lymphocytic Leukemia Stage A(II); Chronic Lymphocytic Leukemia Stage A(0)

• Registration Number: NCT00917540
• Lead Sponsor: Gruppo Italiano Studio Linfomi

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 guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.

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 registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).	6 months

Secondary Outcome Measures

Name	Time	Method
Time to Treatment	6 months
Overall Survival	3 years
Quality of Life	6 months

Trial Locations

Locations (1)

GISL Trial Office; 🇮🇹 Modena, Italy