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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT03357172

Collaborator

(none)

700

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Hematopoietic Stem Cell Transplantation	Biological: Blood Sample Biological: Bone marrow aspiration Biological: Blood sample Biological: Allogeneic hematopoietic stem cell sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportions of regulatory immune cells in peripheral blood. [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]

Secondary Outcome Measures

Occurrence of graft versus host (GVH) reaction after allografting of CSH [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
Incidence of relapse [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
Incidence of infections [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
Progress-free survival [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
Overall survival [After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Nancy	Vandoeuvre Les Nancy		France	54511

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT03357172

Other Study ID Numbers:

2018-A03267-48

First Posted:

Nov 29, 2017

Last Update Posted:

Oct 14, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Central Hospital, Nancy, France

Immune recovery

Immunomodulatory cells

GVHD

GVL

Study Results

No Results Posted as of Oct 14, 2019