Trials / Unknown

UnknownNCT00917540

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

Prospective Collection of Biological Data of Prognostic Relevance in Patients

Status: Unknown
Phase: —
Study type: Observational
Enrollment: 495 (estimated)

Sponsor: Gruppo Italiano Studio Linfomi · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

Conditions

Timeline

Start date: 2007-02-01
Completion: 2013-04-01
First posted: 2009-06-10
Last updated: 2013-04-09

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00917540. Inclusion in this directory is not an endorsement.