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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Biological: Bone marrow aspiration; Biological: Allogeneic hematopoietic stem cell sample; Biological: Blood sample; Biological: Blood Sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03357172

2018-A03267-48

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Recipient

Experimental group

Treatment:

Biological: Blood Sample

Biological: Bone marrow aspiration

Donor

Experimental group

Treatment:

Biological: Blood sample

Biological: Allogeneic hematopoietic stem cell sample