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CompletedNCT03449745ICAML-LICUpdated Apr 20, 2022

Immune Checkpoint Receptors in AML-Leukemic Initiating Cells

An observational study in Acute Myeloid Leukemia, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
199
Ages
18 Years and older
Sex
All
01

Study summary

This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

Read the detailed description

Leukemic Initiating Cells (LIC) were shown to play a key role in AML relapses, and are characterized by resistance to treatment and a high capacity to escape to immune system. Immune checkpoints (ICP) maintain self-tolerance and physiological amplitude of the immune response. We decided to focus our work on ICP receptors and ligand that could be expressed by AML LIC and lymphocytes subsets. The tumor cells are able to express these ligands to exploit the ICP to overcome the anti-cancer immune response. Few studies are published in AML in the field of ICP, some studied limited cohort and others analyzed the expression of these ligands in total leukemic population, with a limited interest since the LIC fraction represents a small subset but mainly contributes to relapse. These cells are rare and their profile of expression could be highly different but not detectable in these studies because of technical limits. We aim at analyzing ICP ligands and receptors expression at diagnosis and relapse, the phenotype of BM cells will be analyzed by flow cytometry according to different panels of monoclonal antibodies using standard immunostaining protocols.

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • Acute Myeloid Leukemia
  • Immune Checkpoint Ligand
  • Flow Cytometry
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Acute Myeloid Leukemia

Inclusion criteria

  • ≥ 18 years of age
  • newly diagnosed AML

Exclusion criteria

Exclusion Criteria:

  • isolated extramedullary AML
  • mixed phenotype acute leukemia
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
199 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Immune checkpoints (ICP) ligand expression

    Compare large panel of ICP ligand expression between LIC and HSC by flow cytometry

    Time frame: At inclusion

Secondary outcomes

  1. Levels of ICP ligand expression

    Compare levels of ICP ligand expression according to FAB classification, cytogenetic classification and molecular abnormalities

    Time frame: At inclusion

  2. Levels of ICP ligand expression

    Study levels of ICP ligand expression on minimal residual disease

    Time frame: At inclusion

06

Study locations

1 site
  • CHU de Bordeaux
    Bordeaux, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449745
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
May 29, 2018
Primary completion
Jun 9, 2021
Completion
Jun 9, 2021
Last update
Apr 20, 2022

Study contacts

Edouard FORCADE
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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