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NCT Number: NCT04517656

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Caroline Lejeune, MD

SUB_INVESTIGATOR

Denis Guyotat, PhD

SUB_INVESTIGATOR

Elisabeth Daguenet, PhD

CONTACT

Emmanuelle Tavernier, MD

SUB_INVESTIGATOR

Jérôme Cornillon, MD

CONTACT

Jérôme Cornillon, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Blood Samples

Other

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.

Primary outcomes

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

  4. Expression level of Elafin plasmatic biomarkers

    Time frame: 12 months

    Expression level of Elafin plasmatic biomarkers will be quantified

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Daguenet, PhD

CONTACT

[email protected]

477917089 ext. +33

Jérôme Cornillon, MD

CONTACT

[email protected]

477917089 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Institut de Cancérologie de la Loire
  • Jean Monnet University

Registry information

Official study title

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

Acronym: MENTALO

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 18, 2020
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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