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RecruitingNCT04517656MENTALOUpdated Apr 9, 2025

Biomarkers Impact Evaluation on the Post-transplant Immune Response After Allografting of Hematopoietic Stem Cells

An interventional study of Blood samples in Malignant Hemopathy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Chemotherapy or targeted therapy are usually used to treat hematological pathologies. Despite of medical improvement, some of these pathologies present drug resistances, or high risk of relapse. Hematopoietic stem cell (HSC) transplantation remain the gold standard of consolidation, to maintain a durable response. In this situation, allograft with hematopoietic stem cells donor aims at producing Graft-versus-Tumor effect, by producing a new immune system, reproducing anti-tumoral immunity.

However, all hemopathies do not have the same sensibility. Nowadays, mechanisms underlying this phenomenon remain poorly understood.

Indeed, few data precisely document the expression of immunological checkpoints and other biomarkers in the context of allogeneic HSC transplantation, particularly their impact on post-transplant outcome.

Read the detailed description

Chemotherapy or targeted therapy are usually used to treat hematological pathologies. Despite of medical improvement, some of these pathologies present drug resistances, or high risk of relapse. Hematopoietic stem cell (HSC) transplantation remain the gold standard of consolidation, to maintain a durable response. In this situation, allograft with hematopoietic stem cells donor aims at producing Graft-versus-Tumor effect, by producing a new immune system, reproducing anti-tumoral immunity.

However, all hemopathies do not have the same sensibility. Nowadays, mechanisms underlying this phenomenon remain poorly understood.

Indeed, few data precisely document the expression of immunological checkpoints and other biomarkers in the context of allogeneic HSC transplantation, particularly their impact on post-transplant outcome. Therefore, we want to systematically study the expression profile of different biomarkers during allogeneic transplantation, in order to establish a correlation between these expression patterns and post-transplant outcome. Ultimately, this research will enable to (i) have tools to predict the post-transplant response and (ii) define whether a targeted therapy could be beneficial or be contraindicated for adequate patient management.

Patients will be selected for the study once they meet all the inclusion criteria. The study will be proposed to them during the pre-allogeneic consultation as part of their usual care. This study does not modify the treatment or the usual management of patients according to the current practice of pre- and post-transplant management. Clinically, it consists of building up a relevant biological collection.

02

Conditions studied

  • Malignant Hemopathy

Keywords

  • Allograft
  • Hematopoietic stem cells
  • Biomarkers
  • Immune response
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patient, over 18 years of age, suffering from a malignant hemopathy (without exception),
  • Patient for whom an allogeneic hematopoietic stem cell transplant from a related or unrelated donor is indicated,
  • Signed informed consent,
  • Patient covered by a social security scheme.

Exclusion criteria

Exclusion Criteria:

  • Allogeneic hematopoietic stem cell transplantation from cord blood or haplo-identical transplant,
  • Allogeneic transplant with post-transplant cyclophosphamide treatment,
  • Allograft with sequential conditioning.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    patients with hematologic malignancy

    Adult patient, over 18 years old, suffering from a malignant hemopathy (without exception) for whom an allogeneic hematopoietic stem cell transplant from a related or unrelated donor is indicated

    Other: Blood samples

Interventions

  • OtherBlood samples

    A peripheral blood sample will be taken and will include 2 EDTA tubes of 5 mL, for a total volume of 10 mL: * Samples before the allograft, * Samples at different times post-allograft: 15 days, 30 days, 60 days, 90 days, 180 days, 360 days, * Samples in the event of the occurrence of concomitant events during the 12-month follow-up period: occurrence of acute Graft Versus Host Disease, chronic Graft Versus Host Disease, or relapse of the disease before the initiation of a new treatment.

06

What researchers measure

Primary outcomes

  1. Expression level of Programmed death-ligand (PD) plasmatic biomarkers

    Expression level of Programmed death-ligand (PD) plasmatic biomarkers will be quantified

    Time frame: 12 months

  2. Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers

    Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers will be quantified

    Time frame: 12 months

  3. Expression level of Reg3 (regenerating islet-derived 3-alpha) plasmatic biomarkers

    Expression level of Reg3 (regenerating islet-derived 3-alpha) plasmatic biomarkers will be quantified

    Time frame: 12 months

  4. Expression level of Elafin plasmatic biomarkers

    Expression level of Elafin plasmatic biomarkers will be quantified

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • CHU de Saint-Etienne
    Saint-Etienne, 42055, France
    • Jérôme Cornillon, MD · Contact
    • Elisabeth Daguenet, PhD · Contact
    • Jérôme Cornillon, MD · Principal investigator
    • Denis Guyotat, PhD · Sub investigator
    • Caroline Lejeune, MD · Sub investigator
    • Emmanuelle Tavernier, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04517656
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire, Jean Monnet University
Responsible party
Sponsor
First posted
Aug 18, 2020
Start date
May 25, 2022
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Jérôme Cornillon, MD
Contact
elisabeth.daguenet@chu-st-etienne.fr
477917089 ext. +33
Elisabeth Daguenet, PhD
Contact
elisabeth.daguenet@chu-st-etienne.fr
477917089 ext. +33
Jérôme Cornillon, MD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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