- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03280290
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft (CCR7-CD4-DPL)
Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
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.
Studieoversigt
Detaljeret beskrivelse
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 .
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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LIlle, Frankrig, 59037
- Diseases of Blood Service HURIEZ hospital CHRU de LILLE
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: receivers
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assessment pre-donation of hematopoietic stem cells (blood sample)
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Eksperimentel: Donors
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assessment pre-donation of hematopoietic stem cells (blood sample)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Tidsramme: 1 day, 5 day ,8 day
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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.
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1 day, 5 day ,8 day
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Change the functional properties of cells will be evaluated by T-SPOT TB®.
Tidsramme: 1 day, 5 day ,8 day
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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.
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1 day, 5 day ,8 day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Response to anti-infectious immunity
Tidsramme: 24 months
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Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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Response to anti-tumor immunity
Tidsramme: 24 months
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Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: YAKOUB-AGHA IBRAHIM, Professor, CHRU de Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010_09
- 2010-A01231-38 (Anden identifikator: ID-RDB number, ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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