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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allogeneic Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Biological: Blood Sample
* Biological: Bone marrow aspiration
* Biological: Blood sample
* Biological: Allogeneic hematopoietic stem cell sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recipient<br> | Biological: Blood Sample<br>* Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2<br>Biological: Bone marrow aspiration<br>* Additional bone marrow aspiration before graft, D30, D90, Y1<br>|
| Experimental: Donor<br> | Biological: Blood sample<br>* Before donation<br>Biological: Allogeneic hematopoietic stem cell sample<br>* Allogeneic hematopoietic stem cell sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune recovery, Immunomodulatory cells, GVHD, GVL