Immune Checkpoint Receptors in AML-Leukemic Initiating Cells

Acute Myeloid Leukemia Clinical Trial

— ICAML-LIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449745
• Other study ID #: CHUBX 2016/37
• Status: Completed
• Start date: May 29, 2018
• Est. completion date: June 9, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• newly diagnosed AML

Exclusion Criteria:

• isolated extramedullary AML

• mixed phenotype acute leukemia

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune checkpoints (ICP) ligand expression	Compare large panel of ICP ligand expression between LIC and HSC by flow cytometry	At inclusion
Secondary	Levels of ICP ligand expression	Compare levels of ICP ligand expression according to FAB classification, cytogenetic classification and molecular abnormalities	At inclusion
Secondary	Levels of ICP ligand expression	Study levels of ICP ligand expression on minimal residual disease	At inclusion