Status:
COMPLETED
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft
Lead Sponsor:
University Hospital, Lille
Conditions:
Acute Myeloblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 partia...
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 partia...
Eligibility Criteria
Inclusion
- 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 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.
Key Trial Info
Start Date :
March 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03280290
Start Date
March 20 2012
End Date
April 1 2017
Last Update
September 12 2017
Active Locations (1)
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1
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
Lille, France, 59037