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Recruiting NCT04517656

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

No phase Interventional Malignant Hemopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples.
Who it may be relevant to
Registry conditions: Malignant Hemopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Expression level of Programmed death-ligand (PD) plasmatic biomarkers [Time frame: 12 months]
  • Expression level of ST2 (suppression of tumourigenicity 2) plasmatic biomarkers [Time frame: 12 months]
  • Expression level of Reg3 (regenerating islet-derived 3-alpha) plasmatic biomarkers [Time frame: 12 months]
  • Expression level of Elafin plasmatic biomarkers [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT04517656 · 2020-0601 · 2020-A01901-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗