Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation (REAL-GREFFE)

October 10, 2019 updated by: Central Hospital, Nancy, France
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54511
        • Recruiting
        • CHRU de Nancy
        • Contact:
          • Marie-Thérèse RUBIO, Pr
          • Phone Number: 0383153030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • Positive HIV
  • active hepatitis B or C infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recipient
Biological: Blood Sample
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
Biological: Bone marrow aspiration
Additional bone marrow aspiration before graft, D30, D90, Y1
Experimental: Donor
Biological: Blood sample
Before donation
Biological: Allogeneic hematopoietic stem cell sample
Allogeneic hematopoietic stem cell sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of relapse
Time Frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of infections
Time Frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Progress-free survival
Time Frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Overall survival
Time Frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

September 30, 2026

Study Completion (Anticipated)

September 30, 2026

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-A03267-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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