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

8 september 2017 uppdaterad av: University Hospital, Lille

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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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 .

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • LIlle, Frankrike, 59037
        • Diseases of Blood Service HURIEZ hospital CHRU de LILLE

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
assessment pre-donation of hematopoietic stem cells (blood sample)
Experimentell: 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
assessment pre-donation of hematopoietic stem cells (blood sample)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Tidsram: 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.
1 day, 5 day ,8 day
Change the functional properties of cells will be evaluated by T-SPOT TB®.
Tidsram: 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.
1 day, 5 day ,8 day

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Response to anti-infectious immunity
Tidsram: 24 months
Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
24 months
Response to anti-tumor immunity
Tidsram: 24 months
Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
24 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: YAKOUB-AGHA IBRAHIM, Professor, CHRU de Lille

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 mars 2012

Primärt slutförande (Faktisk)

1 april 2017

Avslutad studie (Faktisk)

1 april 2017

Studieregistreringsdatum

Först inskickad

24 juni 2014

Först inskickad som uppfyllde QC-kriterierna

8 september 2017

Första postat (Faktisk)

12 september 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 september 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2017

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2010_09
  • 2010-A01231-38 (Annan identifierare: ID-RDB number, ANSM)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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