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

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ClinicalTrials.gov Identifier: NCT04517656
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
GIMAP EA3064 - Saint-Etienne
Institut de Cancérologie de la Loire
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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.


Condition or disease Intervention/treatment Phase
Malignant Hemopathy Other: Blood samples Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Biomarkers Impact Evaluation on the Post-transplant Immune Response After Allografting of Hematopoietic Stem Cells: MENTALO Study
Estimated Study Start Date : February 15, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517656


Contacts
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Contact: Jérôme Cornillon, MD 477917089 ext +33 elisabeth.daguenet@chu-st-etienne.fr
Contact: Elisabeth Daguenet, PhD 477917089 ext +33 elisabeth.daguenet@chu-st-etienne.fr

Locations
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France
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Contact: Jérôme Cornillon, MD         
Contact: Elisabeth Daguenet, PhD         
Principal Investigator: Jérôme Cornillon, MD         
Sub-Investigator: Denis Guyotat, PhD         
Sub-Investigator: Caroline Lejeune, MD         
Sub-Investigator: Emmanuelle Tavernier, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
GIMAP EA3064 - Saint-Etienne
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Jérôme Cornillon, MD CHU de Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04517656    
Other Study ID Numbers: 2020-0601
2020-A01901-38 ( Other Identifier: N° IDRCB )
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Allograft
Hematopoietic stem cells
Biomarkers
Immune response