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

University Hospital, Lille

Status: Completed

Conditions: Acute Myeloblastic Leukemia

Treatments: Biological: blood

Study type: Interventional

Funder types: Other

Identifiers

NCT03280290

2010_09

2010-A01231-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

receivers

Experimental group

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.

Treatment:

Biological: blood

Donors

Experimental group

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

Treatment:

Biological: blood