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

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ClinicalTrials.gov Identifier: NCT00934986
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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).


Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Other: Surface expression of functional biomarkers of the NK cell

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia
Study Start Date : March 2008
Primary Completion Date : March 2010
Study Completion Date : September 2010



Intervention Details:
    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.


Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934986


Locations
France
Institut PAOLI-CALMETTES
Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Thérèse AURRAN-SCHLEINITZ, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00934986     History of Changes
Other Study ID Numbers: LLC-NK/IPC 2007-004
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Institut Paoli-Calmettes:
Chronic Lymphocytic Leukemia
NK Cells

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell