Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia (LLC-NK)

Institut Paoli-Calmettes

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Treatments: Other: Surface expression of functional biomarkers of the NK cell

Study type: Interventional

Funder types: Other

Identifiers

NCT00934986

LLC-NK/IPC 2007-004

Details and patient eligibility

About

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).

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)