NCT04517656

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
May 2022Sep 2026

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3.4 years

First QC Date

August 14, 2020

Last Update Submit

April 7, 2025

Conditions

Malignant Hemopathy

Keywords

AllograftHematopoietic stem cellsBiomarkersImmune response

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

patients with hematologic malignancy

EXPERIMENTAL

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

Interventions

Blood samplesOTHER

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.

patients with hematologic malignancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Allogeneic hematopoietic stem cell transplantation from cord blood or haplo-identical transplant,
  • Allogeneic transplant with post-transplant cyclophosphamide treatment,
  • Allograft with sequential conditioning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jérôme Cornillon, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme Cornillon, MD

CONTACT

477917089elisabeth.daguenet@chu-st-etienne.fr

Elisabeth Daguenet, PhD

CONTACT

477917089elisabeth.daguenet@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

May 25, 2022

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)