Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Sample, Bone marrow aspiration, Blood sample, Allogeneic hematopoietic stem cell sample.
- Who it may be relevant to
- Registry conditions: Allogeneic Hematopoietic Stem Cell Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Biological Blood Sample
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2 - Biological Bone marrow aspiration
Additional bone marrow aspiration before graft, D30, D90, Y1 - Biological Blood sample
Before donation - Biological Allogeneic hematopoietic stem cell sample
Allogeneic hematopoietic stem cell sample
Primary outcome measures
- 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 outcome measures (5)
- 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]
- Incidence of relapse [Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
- Incidence of infections [Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
- Progress-free survival [Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
- Overall survival [Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU de Nancy — Vandœuvre-lès-Nancy
Publications
- Notarantonio AB, Morisset S, Piucco R, Peres M, Boulange L, Alitcher A, Brouard J, Monchablon L, Campidelli A, El Ouahabi S, Guisnel C, Moulin C, Kicki C, Roth-Guepin G, Feugier P, Bittencourt MC, Aarnink A, D'Aveni-Piney M, Hergalant S, Pagliuca S, Rubio MT. Differential Clinical and Immunological Impacts of Anti-T-Lymphocyte Globulin (ATLG) vs. Anti-Thymocyte Globulin (ATG) in Preventing Graft-V PMID 39905816
- Notarantonio AB, Bertrand A, Piucco R, Fievet G, Sartelet H, Boulange L, de Isla N, De Carvalho Bittencourt M, Hergalant S, Rubio MT, D'Aveni M. Highly immunosuppressive myeloid cells correlate with early relapse after allogeneic stem cell transplantation. Exp Hematol Oncol. 2024 May 11;13(1):50. doi: 10.1186/s40164-024-00516-4. PMID 38734654
Identifiers
NCT: NCT03357172 · 2018-A03267-48