Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

8. september 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert 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 .

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Eksperimentell: 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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Tidsramme: 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®.
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mars 2012

Primær fullføring (Faktiske)

1. april 2017

Studiet fullført (Faktiske)

1. april 2017

Datoer for studieregistrering

Først innsendt

24. juni 2014

Først innsendt som oppfylte QC-kriteriene

8. september 2017

Først lagt ut (Faktiske)

12. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. september 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2010_09
  • 2010-A01231-38 (Annen identifikator: ID-RDB number, ANSM)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Akutt myeloblastisk leukemi

Kliniske studier på blood

Abonnere