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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03357172
Acronym
REAL-GREFFE
Enrollment
700
Registered
2017-11-29
Start date
2019-10-01
Completion date
2026-09-30
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Immune recovery, Immunomodulatory cells, GVHD, GVL

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.

Interventions

BIOLOGICALBlood Sample

Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2

BIOLOGICALBone marrow aspiration

Additional bone marrow aspiration before graft, D30, D90, Y1

BIOLOGICALBlood sample

Before donation

BIOLOGICALAllogeneic hematopoietic stem cell sample

Allogeneic hematopoietic stem cell sample

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Occurrence of graft versus host (GVH) reaction after allografting of CSHAfter 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of relapseAfter 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of infectionsAfter 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Progress-free survivalAfter 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Overall survivalAfter 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Countries

France

Contacts

Primary ContactMarie-Thérèse RUBIO, PU-PH
m.rubio@chru-nancy.fr0383153257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026