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

Not Applicable

Recruiting

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
• Interventions: Biological: Blood sample; Biological: Bone marrow aspiration; Biological: Allogeneic hematopoietic stem cell sample

• Registration Number: NCT03357172
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-29
• Status Verified: 2019-10
• Study Start: 2019-10-01
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor	Blood sample	-
Recipient	Blood sample	-
Recipient	Bone marrow aspiration	-
Donor	Allogeneic hematopoietic stem cell sample	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre Les Nancy, France