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COMPLETED
NCT04965649

Is There an Association Between Innate CD8+ T Cells and the Evolution of Tyrosine Kinase Inhibitor Resistance Mutations in Phi+ Hematological Malignancies.

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

Summary

The aim of this project is to test whether low levels of BcrAbl1, despite the presence of resistance mutations, are related to high levels of innate CD8+ T cells, in the hypothesis that these cells have an anti-tumor role. This research aims to investigate: * An association between the rate of innate CD8+ T cells and the evolution of Phi+ pathologies (Chronic Myeloid Leukemia and Philadelphia chromosome-positive Acute lymphocytic leukemia (Phi+ ALL) carrying a resistance mutation, according to the ELN 2013 and Phi LMC recommendations. * An association between the level of innate CD8+ T cells and the expansion of TKI resistance clones, assessed as the number of BcrAbl1 copies carrying the mutation relative to the number of Abl1 copies.

Official title: Search for an Association Between the Innate CD8+ T Cell Population and the Evolution of TKI (Tyrosine Kinase Inhibitor) Resistance Mutations in Phi+ Hematological Malignancies.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2021-01-01

Completion Date

2026-05-26

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

GENETIC

Phenotyping of total and innate CD8+T cells by flow cytometry

Blood samples from patients in the active file of the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital will be analyzed (diagnosis already known). Samples will be representative of the different stages of the pathology. For patients with a confirmed diagnosis of Chronic Myeloid Leukemia and Philadelphia+ Acute Lymphoblastic Leukemia), the remaining whole blood sample taken as part of the usual management will be sent for phenotyping of CD8+ TL (total and innate) by flow cytometry. Phenotyping will be performed on samples pooled at the end of the recruitment period.

Locations (1)

CHU de Nîmes

Nîmes, Gard, France