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

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

— REAL-GREFFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03357172
• Other study ID #: 2018-A03267-48
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2026

Study information

• Verified date: October 2019
• Source: Central Hospital, Nancy, France
• Contact: Marie-Thérèse RUBIO, PU-PH
• Phone: 0383153257
• Email: m.rubio[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

Biological:
• Blood Sample
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
• Bone marrow aspiration
Additional bone marrow aspiration before graft, D30, D90, Y1
• Blood sample
Before donation
• Allogeneic hematopoietic stem cell sample
Allogeneic hematopoietic stem cell sample

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of relapse		After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Secondary	Incidence of infections		After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Secondary	Progress-free survival		After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Secondary	Overall survival		After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years