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

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Hemopathy
• Intervention / Treatment: Other: Blood samples

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme Cornillon, MD; Phone Number: +33 477917089; Email: elisabeth.daguenet@chu-st-etienne.fr
• Study Contact Backup: Name: Elisabeth Daguenet, PhD; Phone Number: +33 477917089; Email: elisabeth.daguenet@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Jérôme Cornillon, MD
    • Principal Investigator: Jérôme Cornillon, MD
    • Contact: Elisabeth Daguenet, PhD
    • Sub-Investigator: Denis Guyotat, PhD
    • Sub-Investigator: Caroline Lejeune, MD
    • Sub-Investigator: Emmanuelle Tavernier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression level of Programmed death-ligand (PD) plasmatic biomarkers	Expression level of Programmed death-ligand (PD) plasmatic biomarkers will be quantified	12 months
Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers	Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers will be quantified	12 months
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	12 months
Expression level of Elafin plasmatic biomarkers	Expression level of Elafin plasmatic biomarkers will be quantified	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire; Université Jean Monnet de Saint-Etienne
• Investigators: Principal Investigator: Jérôme Cornillon, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; Immune response; Allograft; Hematopoietic stem cells
• Other Study ID Numbers: 2020-0601; 2020-A01901-38 (Other Identifier: N° IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No