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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00934986
First received: July 2, 2009
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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 Intervention
Chronic Lymphocytic Leukemia
Other: Surface expression of functional biomarkers of the NK cell

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934986

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

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00934986     History of Changes
Other Study ID Numbers: LLC-NK/IPC 2007-004
Study First Received: July 2, 2009
Last Updated: September 13, 2011
Health Authority: France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on July 24, 2014