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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00917540
Other study ID # O-CLL1
Secondary ID
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.


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Study Design

Observational Model: Cohort, Time Perspective: Prospective


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
See also
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Active, not recruiting NCT06377501 - Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) N/A