Skip to main content
OpenTrials
Completed

NCT Number: NCT03449745

Immune Checkpoint Receptors in AML-Leukemic Initiating Cells

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • newly diagnosed AML

Exclusion criteria

  • isolated extramedullary AML
  • mixed phenotype acute leukemia

Treatment and study plan

Primary outcomes

  1. Immune checkpoints (ICP) ligand expression

    Time frame: At inclusion

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

Secondary outcomes

  1. Levels of ICP ligand expression

    Time frame: At inclusion

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

  2. Levels of ICP ligand expression

    Time frame: At inclusion

    Study levels of ICP ligand expression on minimal residual disease

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Analysis of Immune Checkpoint Receptors Expression in the LIC Fraction pf AML Cells - ICAML-LIC

Acronym: ICAML-LIC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.