NCT00934986

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

July 2, 2009

Last Update Submit

September 13, 2011

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaNK Cells

Outcome Measures

Primary Outcomes (1)

  • Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.

    1 day

Interventions

Surface expression of functional biomarkers of the NK cellOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patient with anemia: haemoglobin \< 9 g/dl
  • Pregnancy, breast feeding
  • Patient in an urgent situation, or unable to give a consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut PAOLI-CALMETTES

Marseille, France

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thérèse AURRAN-SCHLEINITZ, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 8, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

FR(1)