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NCT04965649Completed

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

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.

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
30 (actual)
First submitted
8 Jul 2021
Start date
1 Jan 2021
Primary completion date
26 May 2026
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
NCT number
NCT04965649

What you commit to

  • Study type: Observational
  • Participants enrolled: 30
  • From 1 Jan 2021 to the primary completion date, 26 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Patients Under 18 years of age

Other

  • Blast crisis stage pathology (according to WHO 2017 criteria (Table2.01, p33, WHO classification of tumours of haematopoietic and lymphoid tissues, IARC 2017).

Who the study is looking for

  • Chronic Myeloid Leukemia or Phi+ ALL patients with TKI resistance mutations being monitored by the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital.
  • Pathology resulting from a BcrAbl1 fusion gene (CML or Phi+ ALL) and presence of a TKI resistance mutation.
  • Patients affiliated to or beneficiaries of a health insurance scheme.
  • Adult patients over18 years of age.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Nîmes
Coordinator of this site? Confirm its status
NîmesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.