Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft

NCT ID: NCT03280290

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-20
• Study Completion Date: 2017-04-30

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 .

Conditions

Acute Myeloblastic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

blood

Intervention Type: BIOLOGICAL

assessment pre-donation of hematopoietic stem cells (blood sample)

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

Group Type: EXPERIMENTAL

blood

Intervention Type: BIOLOGICAL

assessment pre-donation of hematopoietic stem cells (blood sample)

Interventions

blood

assessment pre-donation of hematopoietic stem cells (blood sample)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YAKOUB-AGHA IBRAHIM, Professor

Role: STUDY_DIRECTOR

CHRU de Lille

Locations

Diseases of Blood Service HURIEZ hospital CHRU de LILLE

Lille, , France

Countries

France

Other Identifiers

2010-A01231-38

Identifier Type: OTHER

Identifier Source: secondary_id

2010_09

Identifier Type: -

Identifier Source: org_study_id