Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia (LLC-NK)
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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 |
- 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) |
-
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 :
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 |
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 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 May 16, 2013