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
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||Phase|
|Chronic Lymphocytic Leukemia||Other: Surface expression of functional biomarkers of the NK cell||Not Applicable|
Method: prospective, monocentric, descriptive study
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.
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|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||September 2010|
Other: Surface expression of functional biomarkers of the NK cell
- 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.
An extra blood sample of 40 ml is required :
- 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 ]
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
|Principal Investigator:||Thérèse AURRAN-SCHLEINITZ, MD||Institut Paoli-Calmettes|