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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Positive HIV

active hepatitis B or C infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Sample

    Biological/Vaccine

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

  • Bone marrow aspiration

    Biological/Vaccine

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

  • Blood sample

    Biological/Vaccine

    Before donation

  • Allogeneic hematopoietic stem cell sample

    Biological/Vaccine

    Allogeneic hematopoietic stem cell sample

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: RecipientExperimental treatment 2 interventions
Group B: DonorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportions of regulatory immune cells in peripheral blood.

Time frame
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Secondary outcomes

1

Occurrence of graft versus host (GVH) reaction after allografting of CSH

Time frame
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
2

Incidence of relapse

Time frame
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
3

Incidence of infections

Time frame
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
4

Progress-free survival

Time frame
After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Other outcomes

Sponsors and contacts

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