ClinicalTrials.gg
Status unknownNCT03294824Allo-NK-CMVUpdated May 29, 2018

Non Randomized Comparative Study With Control

An observational study in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Adenoviridae Infections with a site in France — 3 open to participants now, 3 under way, 2 of them phase 3. Adenoviridae Infections · France.

Started
2013
the only one that year
Observational
3 of 11
none open now
Registered
4th of 11
by date
Lead sponsor
3 of 11
Assistance Publique - Hôpitaux de Paris

Among the 11 studies in Adenoviridae Infections with a site in France, this one is the only one that started in 2013, is one of 3 observational ones, and was the 4th registered.

Adenoviridae Infections

136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.

Browse Adenoviridae Infections studies →

Open to participants now

3 of the 11 studies in Adenoviridae Infections with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 25 Adenoviridae Infections studies recruiting now, 9 (36%) set no upper age limit and 12 (48%) stop at 75 or younger; 17 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the detailed 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).

03

Conditions studied

  • Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

  • NK cells
  • Cytomegalovirus
  • adenovirus
  • Allogeneic transplantation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Allogeneic HSCT for malignant or non malignant hematological disease in adult patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. patients who reactivate CMV or AdV after 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 ;
  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

Exclusion Criteria:

none

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients who reactivate CMV or AdV after allogeneic HSCT

    allotransplanted patients who reactivated respectively CMV (n=30) and AdV (n=10)

    Other: blood sample

  • Control group: allogeneic HSC transplanted patients

    allotransplanted patients who didn't reactivate CMV

    Other: blood sample

  • Healthy donors group

    healthy donors serologically + for CMV

    Other: blood sample

Interventions

  • Otherblood sample

    peripheral blood samples are collected

06

What researchers measure

Primary outcomes

  1. Nk cells phenotype (activation, differentiation, memory NK cell) and function (cytoxicity and cytokines production) measured by flow cytometry

    CD3-CD56+ NK cells will be analyzed by Flow cytometry with an appropriate monoclonal antibodies (mAb) cocktail: anti-CD3 ,CD56, CD16, CD159a/NKG2A , CD85J; HLA-DR ; CD62L , CD161; KIR2DL1 and KIR3DL1, and KIR2DL2/KIR2DL3. The state of NK cells differentiation and maturation will be assessed by the analyze of thoses phenotypic markers and will be compared with healthy donors.

    Time frame: Change from "before antiviral treatment", " half treatment" (1 week or 2 week after the beginning of the treatment), 1 month "post treatment" and 3 month "post treatment"

  2. NK cells cytoxicity and cytokines production when incubated with standard HLA class I negative K562 target cells

    Polyfunctional assay will test the capacity of NK cells degranulation and production of cytokines when incubated with standard HLA class I negative K562 target cells in the presence of anti-CD107a ,IFN-g, or TNF-a mAb. The state of NK cells differentiation and maturation will be assessed by the analyze of thoses phenotypic and will be compared with healthy donors.

    Time frame: Change from "before antiviral treatment", " half treatment" (1 week or 2 week after the beginning of the treatment), 1 month "post treatment" and 3 month "post treatment"

Secondary outcomes

  1. Effect of CMV and AdV infection compared with healthy donors

    The state of NK cells differentiation and maturation will be assessed by the analyze of thoses phenotypic and functional markers and will be compared with healthy donors.

    Time frame: Change from "before antiviral treatment", " half treatment" (1 week or 2 week after the beginning of the treatment), 1 month "post treatment" and 3 month "post treatment"

  2. In vitro Nk cells ligands analyzes on infected cells by CMV

    Monocyte are differentiated in macrophage cells and infected by the CMV strain TB40/E. Nk cell ligands will be analyzed on infected cells. NK cells from infected patients post allogenic transplantation will be tested against in vitro infected cells. Being a model in vitro, it is not possible to determine in advance which ligands will be identified.

    Time frame: approximately 18 months after Study Completion Date (last participant's last visit)

07

Study locations

1 of 1 sites recruiting
  • Hôpital Pitié Salpêtriere
    Paris, 75651, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2013 (actual). Primary completion is estimated for Jun 2018, 57 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2016
First posted
Sep 27, 2017
StartActual
Sep 27, 2013
Primary completionEst.
Jun 2018
CompletionEst.
Jun 2018
Last update
May 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03294824
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Sep 27, 2013
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
May 29, 2018

Study contacts

Stephanie Nguyen Quoc, Doctor
Contact
stephanie.nguyen-quoc@aphp.fr
33142162823
Laetitia Souchet, Doctor
Contact
33142162823
Stephanie Nguyen Quoc, Doctor
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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