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

Malignant Hemopathy Clinical Trial

— MENTALO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517656
• Other study ID #: 2020-0601
• Secondary ID: 2020-A01901-38
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jérôme Cornillon, MD
• Phone: 477917089
• Email: elisabeth.daguenet[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Hemopathy

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire, Université Jean Monnet de Saint-Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression level of Programmed death-ligand (PD) plasmatic biomarkers	Expression level of Programmed death-ligand (PD) plasmatic biomarkers will be quantified	12 months
Primary	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
Primary	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
Primary	Expression level of Elafin plasmatic biomarkers	Expression level of Elafin plasmatic biomarkers will be quantified	12 months