Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

NCT ID: NCT00934986

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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

Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* Patient with anemia: haemoglobin \< 9 g/dl
* Pregnancy, breast feeding
* Patient in an urgent situation, or unable to give a consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thérèse AURRAN-SCHLEINITZ, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut PAOLI-CALMETTES

Marseille, , France

Site Status

Countries

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France

Related Links

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http://www.institutpaolicalmettes.fr

Official web site of the sponsor

Other Identifiers

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LLC-NK/IPC 2007-004

Identifier Type: -

Identifier Source: org_study_id

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