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

September 13, 2011 updated by: Institut Paoli-Calmettes

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Institut Paoli-Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Thérèse AURRAN-SCHLEINITZ, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2011

Last Update Submitted That Met QC Criteria

September 13, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLC-NK/IPC 2007-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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