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

NCT ID: NCT03357172

Last Updated: 2019-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2026-09-30

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.

Detailed Description

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Conditions

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Allogeneic Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Recipient

Group Type EXPERIMENTAL

Blood Sample

Intervention Type BIOLOGICAL

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

Bone marrow aspiration

Intervention Type BIOLOGICAL

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

Donor

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

Before donation

Allogeneic hematopoietic stem cell sample

Intervention Type BIOLOGICAL

Allogeneic hematopoietic stem cell sample

Interventions

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Blood Sample

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

Intervention Type BIOLOGICAL

Bone marrow aspiration

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

Intervention Type BIOLOGICAL

Blood sample

Before donation

Intervention Type BIOLOGICAL

Allogeneic hematopoietic stem cell sample

Allogeneic hematopoietic stem cell sample

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie-Thérèse RUBIO, PU-PH

Role: CONTACT

0383153257 ext. +33

Facility Contacts

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Marie-Thérèse RUBIO, Pr

Role: primary

0383153030

References

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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-Versus-Host Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation: A Comparative Study. Am J Hematol. 2025 Apr;100(4):626-637. doi: 10.1002/ajh.27619. Epub 2025 Feb 4.

Reference Type DERIVED
PMID: 39905816 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38734654 (View on PubMed)

Other Identifiers

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2018-A03267-48

Identifier Type: -

Identifier Source: org_study_id

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