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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280290
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Acute Myeloblastic Leukemia Biological: blood Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
Actual Study Start Date : March 20, 2012
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Experimental: receivers
  • 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.
Biological: blood
assessment pre-donation of hematopoietic stem cells (blood sample)

Experimental: Donors
  • 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
Biological: blood
assessment pre-donation of hematopoietic stem cells (blood sample)




Primary Outcome Measures :
  1. Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer [ Time Frame: 1 day, 5 day ,8 day ]
    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.

  2. Change the functional properties of cells will be evaluated by T-SPOT TB®. [ Time Frame: 1 day, 5 day ,8 day ]
    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 :
  1. Response to anti-infectious immunity [ Time Frame: 24 months ]
    Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)

  2. Response to anti-tumor immunity [ Time Frame: 24 months ]
    Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03280290


Locations
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France
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
LIlle, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Study Director: YAKOUB-AGHA IBRAHIM, Professor CHRU de Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03280290    
Other Study ID Numbers: 2010_09
2010-A01231-38 ( Other Identifier: ID-RDB number, ANSM )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
Lymphocytes CD4
Lymphocytes CCR7
ALLOGRAFT
Hematopoietic Stem Cells
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms