Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— LLC-NK  

Official title:

Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934986
• Other study ID #: LLC-NK/IPC 2007-004
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: September 13, 2011
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

Purpose:

The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).

Description:

Method: prospective, monocentric, descriptive study

Primary objective:

Evaluation of the expression and function of receptors activator of NK cell (KIRs) in patients with CLL at stage A with therapeutic abstention, or stage B or C which require a treatment.

Secondary objectives:

Measure of the evolution of cytotoxic function of NK cells and theirs biomarkers of activation when the patient receives an immunochemotherapy with Rituximab/ Fludarabine/ Cyclophosphamide (RCF).

Verification, by analysis, of functions and biomarkers of the adaptive and innate immunity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of CLL (Score of Matutes >=4) with no history of treatment: Stade A of Binet, Or Stade B or C before the beginning of the treatment with RFC

• Patients who can undergo blood collection

• Patient aged 18 years and older

• Signed consent

Non inclusion Criteria:

• Patient with anemia: haemoglobin < 9 g/dl

• Pregnancy, breast feeding

• Patient in an urgent situation, or unable to give a consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Other:
• Surface expression of functional biomarkers of the NK cell
An extra blood sample of 40 ml is required : Stage A patient who does not require a treatment: one sample the day of enrollment. Stage B or C patient who require RFC treatment: sample at D0 of the 1st and 4th cure of RFC, and 3 months after the end of the treatment.

Locations

Country	Name	City	State
France	Institut PAOLI-CALMETTES	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.		1 day	No

External Links

•   Official web site of the sponsor