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

NCT ID: NCT04517656

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2026-09-30

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.

Conditions

Malignant Hemopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Jean Monnet University

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérôme Cornillon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jérôme Cornillon, MD

Role: CONTACT

elisabeth.daguenet@chu-st-etienne.fr

477917089 ext. +33

Elisabeth Daguenet, PhD

Role: CONTACT

elisabeth.daguenet@chu-st-etienne.fr

477917089 ext. +33

Facility Contacts

Jérôme Cornillon, MD

Role: primary

Elisabeth Daguenet, PhD

Role: backup

Other Identifiers

2020-A01901-38

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0601

Identifier Type: -

Identifier Source: org_study_id