search
Back to results

Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft (CCR7-CD4-DPL)

Primary Purpose

Acute Myeloblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myeloblastic Leukemia focused on measuring Lymphocytes CD4, Lymphocytes CCR7, ALLOGRAFT, Hematopoietic Stem Cells

Eligibility Criteria

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

Inclusion Criteria:

Inclusion criteria of the receiver anti -infectious immunity

  • Man or woman aged 18-65 years
  • Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
  • In a complete remission rate of leucocytes with ≥ 2G / L
  • Affiliated to social security person or beneficiary of such a scheme.
  • Having signed informed consent

Inclusion criteria for the study of the receiver of anti tumor immunity

  • Man or woman aged 18-65 years
  • Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)
  • Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme )
  • Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
  • In a complete remission rate of leucocytes with ≥ 2G / L
  • Affiliated to social security person or beneficiary of such a scheme.
  • Having signed informed consent receivers

Inclusion criteria of the donor

  • Man or woman aged 18-65 years
  • Member of the HLA-matched siblings and A, B, Cw, DR, DQ
  • Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
  • Having a rate of circulating lymphocytes ≥ 1 G / L
  • Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
  • The statutes CMV and EBV are known (positive or negative).
  • Affiliated to social security person or beneficiary of such a scheme. who signed informed consent -

Exclusion Criteria:

Criteria for non inclusion of the pairs donor / Receiver

  • Private person of liberty by judicial or administrative decision
  • Person subject to a measure of legal protection
  • Pregnant or breastfeeding woman
  • People do not understand French or understanding with a disability.
  • Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.

Sites / Locations

  • Diseases of Blood Service HURIEZ hospital CHRU de LILLE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

receivers

Donors

Arm Description

Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled) In a complete remission rate of leucocytes with ≥ 2G / L Affiliated to social security person or beneficiary of such a scheme.

Member of the siblings and HLA-matched A, B, Cw, DR, DQ Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled) Having a rate of circulating lymphocytes ≥ 1 G / L Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population The statutes CMV and EBV are known (positive or negative). Affiliated to social security person or beneficiary

Outcomes

Primary Outcome Measures

Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Change the functional properties of cells will be evaluated by T-SPOT TB®.
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.

Secondary Outcome Measures

Response to anti-infectious immunity
Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
Response to anti-tumor immunity
Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)

Full Information

First Posted
June 24, 2014
Last Updated
September 8, 2017
Sponsor
University Hospital, Lille
search

1. Study Identification

Unique Protocol Identification Number
NCT03280290
Brief Title
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft
Acronym
CCR7-CD4-DPL
Official Title
Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 20, 2012 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans. The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.
Detailed Description
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans. The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloblastic Leukemia
Keywords
Lymphocytes CD4, Lymphocytes CCR7, ALLOGRAFT, Hematopoietic Stem Cells

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
receivers
Arm Type
Experimental
Arm Description
Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled) In a complete remission rate of leucocytes with ≥ 2G / L Affiliated to social security person or beneficiary of such a scheme.
Arm Title
Donors
Arm Type
Experimental
Arm Description
Member of the siblings and HLA-matched A, B, Cw, DR, DQ Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled) Having a rate of circulating lymphocytes ≥ 1 G / L Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population The statutes CMV and EBV are known (positive or negative). Affiliated to social security person or beneficiary
Intervention Type
Biological
Intervention Name(s)
blood
Intervention Description
assessment pre-donation of hematopoietic stem cells (blood sample)
Primary Outcome Measure Information:
Title
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Description
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Time Frame
1 day, 5 day ,8 day
Title
Change the functional properties of cells will be evaluated by T-SPOT TB®.
Description
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Time Frame
1 day, 5 day ,8 day
Secondary Outcome Measure Information:
Title
Response to anti-infectious immunity
Description
Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
Time Frame
24 months
Title
Response to anti-tumor immunity
Description
Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria of the receiver anti -infectious immunity Man or woman aged 18-65 years Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled) In a complete remission rate of leucocytes with ≥ 2G / L Affiliated to social security person or beneficiary of such a scheme. Having signed informed consent Inclusion criteria for the study of the receiver of anti tumor immunity Man or woman aged 18-65 years Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L) Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme ) Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled) In a complete remission rate of leucocytes with ≥ 2G / L Affiliated to social security person or beneficiary of such a scheme. Having signed informed consent receivers Inclusion criteria of the donor Man or woman aged 18-65 years Member of the HLA-matched siblings and A, B, Cw, DR, DQ Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled) Having a rate of circulating lymphocytes ≥ 1 G / L Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population The statutes CMV and EBV are known (positive or negative). Affiliated to social security person or beneficiary of such a scheme. who signed informed consent - Exclusion Criteria: Criteria for non inclusion of the pairs donor / Receiver Private person of liberty by judicial or administrative decision Person subject to a measure of legal protection Pregnant or breastfeeding woman People do not understand French or understanding with a disability. Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YAKOUB-AGHA IBRAHIM, Professor
Organizational Affiliation
CHRU de Lille
Official's Role
Study Director
Facility Information:
Facility Name
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
City
LIlle
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft

We'll reach out to this number within 24 hrs