NCT03357172

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2019Sep 2026

First Submitted

Initial submission to the registry

November 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

7 years

First QC Date

November 24, 2017

Last Update Submit

October 10, 2019

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Immune recoveryImmunomodulatory cellsGVHDGVL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Recipient

EXPERIMENTAL
Biological: Blood SampleBiological: Bone marrow aspiration

Donor

EXPERIMENTAL
Biological: Blood sampleBiological: Allogeneic hematopoietic stem cell sample

Interventions

Blood sampleBIOLOGICAL

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

Recipient
Bone marrow aspirationBIOLOGICAL

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

Recipient
Allogeneic hematopoietic stem cell sampleBIOLOGICAL

Allogeneic hematopoietic stem cell sample

Donor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Positive HIV
  • active hepatitis B or C infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39905816DERIVED

  • 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: 38734654DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Marie-Thérèse RUBIO, PU-PH

CONTACT

0383153257m.rubio@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 29, 2017

Study Start

October 1, 2019

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)