- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03357172
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
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
- Name: Marie-Thérèse RUBIO, PU-PH
- Phone Number: +33 0383153257
- Email: m.rubio@chru-nancy.fr
Study Locations
-
-
-
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
|
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
Additional bone marrow aspiration before graft, D30, D90, Y1
|
Experimental: Donor
|
Before donation
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
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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