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Non Randomized Comparative Study With Control (Allo-NK-CMV)

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Treatments

Other: blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT03294824
IDRCB (Other Identifier)
P111107

Details and patient eligibility

About

NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal tolerance. They belong to innate immune cells but they have a link with adaptative immunity. Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of NKG2C+ NK cells expands and can transfer, in murine models, a " memory " that can better control CMV infections. CMV reactivation is a major cause of morbidity and mortality after allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and functional studies before and after administration of anti viral drugs) and compared with 30 allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors serologically + for CMV.

Full description

For both groups: 28ml of peripheral blood samples are collected at different points. Group 1 : before and after anti viral treatment . Control group 2: one point after allo-HSCT; Control group 3: 1 point before transplant. Phenotypical study of NK cells: activating and inhibitory receptors, activation and differentiation's markers. Phenotypical studies of the ligands on infected cells. Genotypic study of KIR receptors (Kirotype); functional studies: polyfunctionality essay (flow cytometry): degranulation CD107a, IFNg, TNFa production).

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. patients who reactivate CMV or AdV after allogeneic HSCT ;

    • Age>18 years; indication for a antiviral treatment:
    • at least 1 PCR CMV>1000 copies/ml or 1 PCR ADV>1000 copies/ml or at least 2 ADV PCR positive - sites (stools, throat, urines);
    • signed informed consent;
  2. Control group: allogeneic HSC transplanted patients;

    • Age>18 years; no CMV or AdV reactivation ;
    • signed informed consent;
  3. Healthy donors group: HSC donor;

    • Age>18 years;
    • signed informed consent

Exclusion criteria

none

Trial design

90 participants in 3 patient groups

patients who reactivate CMV or AdV after allogeneic HSCT
Description:
allotransplanted patients who reactivated respectively CMV (n=30) and AdV (n=10)
Treatment:
Other: blood sample
Control group: allogeneic HSC transplanted patients
Description:
allotransplanted patients who didn't reactivate CMV
Treatment:
Other: blood sample
Healthy donors group
Description:
healthy donors serologically + for CMV
Treatment:
Other: blood sample

Trial contacts and locations

1

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Central trial contact

Stephanie Nguyen Quoc, Doctor; Laetitia Souchet, Doctor

Data sourced from clinicaltrials.gov

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