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

July 2, 2009
September 13, 2011
March 2008
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00934986 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia
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).

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chronic Lymphocytic Leukemia
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00934986
LLC-NK/IPC 2007-004
No
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Thérèse AURRAN-SCHLEINITZ, MD Institut Paoli-Calmettes
Institut Paoli-Calmettes
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP