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

Chronic Lymphocytic Leukemia Stage A(0) Clinical Trial

Official title:

Prospective Collection of Biological Data of Prognostic Relevance in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00917540
• Other study ID #: O-CLL1
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2009
• Last updated: April 5, 2013
• Start date: February 2007
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Gruppo Italiano Studio Linfomi
• Contact: Fortunato Morabito, MD
• Phone: +39 0984 681329
• Email: fortunato_morabito[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 495
• Est. completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia Stage A(0)
• Chronic Lymphocytic Leukemia Stage A(I)
• Chronic Lymphocytic Leukemia Stage A(II)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Italy	GISL Trial Office	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Linfomi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life		6 months	No
Secondary	Time to Treatment		6 months	No
Secondary	Overall Survival		3 years	No