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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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00917540
Study type Observational
Source Gruppo Italiano Studio Linfomi
Contact Fortunato Morabito, MD
Phone +39 0984 681329
Email fortunato_morabito@tin.it
Status Recruiting
Phase N/A
Start date February 2007
Completion date April 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05136378 - Selenious Yeast in CLL Patients w/o Indication of Chemotherapy N/A
Active, not recruiting NCT06377501 - Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) N/A