Immune Checkpoint Receptors in AML-Leukemic Initiating Cells (ICAML-LIC)

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

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

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia

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.

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Acute Myeloid Leukemia

Description

Inclusion Criteria:

• ≥ 18 years of age
• newly diagnosed AML

Exclusion Criteria:

• isolated extramedullary AML
• mixed phenotype acute leukemia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune checkpoints (ICP) ligand expression	Compare large panel of ICP ligand expression between LIC and HSC by flow cytometry	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of ICP ligand expression	Compare levels of ICP ligand expression according to FAB classification, cytogenetic classification and molecular abnormalities	At inclusion
Levels of ICP ligand expression	Study levels of ICP ligand expression on minimal residual disease	At inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Edouard FORCADE, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2018
• Primary Completion (ACTUAL): June 9, 2021
• Study Completion (ACTUAL): June 9, 2021

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Flow Cytometry; Immune Checkpoint Ligand
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: CHUBX 2016/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No