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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surface expression of functional biomarkers of the NK cell
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, NK Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut PAOLI-CALMETTES

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2009
Last Updated
September 13, 2011
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00934986
Brief Title
Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia
Acronym
LLC-NK
Official Title
Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia, NK Cells

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Surface expression of functional biomarkers of the NK cell
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thérèse AURRAN-SCHLEINITZ, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut PAOLI-CALMETTES
City
Marseille
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr
Description
Official web site of the sponsor

Learn more about this trial

Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

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