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RecruitingNCT03357172REAL-GREFFEUpdated Oct 14, 2019

Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation

An interventional study of Blood Sample and Bone marrow aspiration in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.

02

Conditions studied

  • Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

  • Immune recovery
  • Immunomodulatory cells
  • GVHD
  • GVL
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient of the Nancy CHRU, for whom a CSH allograft is planned. or
  • hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research

Exclusion criteria

Exclusion Criteria:

  • Positive HIV
  • active hepatitis B or C infection
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Recipient

    Biological: Blood Sample · Biological: Bone marrow aspiration

  • Experimental
    Donor

    Biological: Blood sample · Biological: Allogeneic hematopoietic stem cell sample

Interventions

  • BiologicalBlood Sample

    Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2

  • BiologicalBone marrow aspiration

    Additional bone marrow aspiration before graft, D30, D90, Y1

  • BiologicalBlood sample

    Before donation

  • BiologicalAllogeneic hematopoietic stem cell sample

    Allogeneic hematopoietic stem cell sample

05

What researchers measure

Primary outcomes

  1. Proportions of regulatory immune cells in peripheral blood.

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Secondary outcomes

  1. Occurrence of graft versus host (GVH) reaction after allografting of CSH

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  2. Incidence of relapse

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  3. Incidence of infections

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  4. Progress-free survival

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  5. Overall survival

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

06

Study locations

1 of 1 sites recruiting
  • CHRU de Nancy
    Vandoeuvre Les Nancy, 54511, France
    • Marie-Thérèse RUBIO, Pr · Contact · 0383153030
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03357172
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Oct 1, 2019
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Oct 14, 2019

Study contacts

Marie-Thérèse RUBIO, PU-PH
Contact
m.rubio@chru-nancy.fr
0383153257 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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