Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00934986

Acronym

LLC-NK

Enrollment

Registered

2009-07-08

Start date

2008-03-31

Completion date

2010-09-30

Last updated

2011-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, NK Cells

Brief 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).

Detailed 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

Interventions

OTHERSurface 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.	1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026