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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04517656
Acronym
MENTALO
Enrollment
40
Registered
2020-08-18
Start date
2022-05-25
Completion date
2026-09-30
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Hemopathy

Keywords

Allograft, Hematopoietic stem cells, Biomarkers, Immune response

Brief 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.

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.

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.

Sponsors

Institut de Cancérologie de la Loire
CollaboratorOTHER
Jean Monnet University
CollaboratorOTHER
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Expression level of Programmed death-ligand (PD) plasmatic biomarkers12 monthsExpression level of Programmed death-ligand (PD) plasmatic biomarkers will be quantified
Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers12 monthsExpression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers will be quantified
Expression level of Reg3 (regenerating islet-derived 3-alpha) plasmatic biomarkers12 monthsExpression level of Reg3 (regenerating islet-derived 3-alpha) plasmatic biomarkers will be quantified
Expression level of Elafin plasmatic biomarkers12 monthsExpression level of Elafin plasmatic biomarkers will be quantified

Countries

France

Contacts

Primary ContactJérôme Cornillon, MD
elisabeth.daguenet@chu-st-etienne.fr477917089
Backup ContactElisabeth Daguenet, PhD
elisabeth.daguenet@chu-st-etienne.fr477917089

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026