Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCR-ABL Positive Acute Myeloid Leukemia | — | UNRESOLVED | — |
| Chronic Leukemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelogenous Leukemia | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phenotyping of total and innate CD8+T cells by flow cytometry | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Chronic Myeloid Leukemia
- description
- There will be approximately 10 patients with Chronic Myeloid Leukemia in this group
- interventionNames
- Genetic: Phenotyping of total and innate CD8+T cells by flow cytometry
- label
- Philadelphia+ Acute Lymphoblastic Leukemia
- description
- There will be approximately 20 patients with Philadelphia chromosome-positive Acute lymphocytic leukemia in this group
- interventionNames
- Genetic: Phenotyping of total and innate CD8+T cells by flow cytometry
Primary outcomes (6)
- measure
- Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: mutated BcrAbl1
- timeFrame
- 1-6 months after collecting last sample
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Blast crisis stage pathology (according to WHO 2017 criteria (Table2.01, p33, WHO classification of tumours of haematopoietic and lymphoid tissues, IARC 2017). * Patients Under 18 years of age
References
Publications (3)
- BACKGROUNDSoverini S, De Benedittis C, Castagnetti F, Gugliotta G, Mancini M, Bavaro L, Machova Polakova K, Linhartova J, Iurlo A, Russo D, Pane F, Saglio G, Rosti G, Cavo M, Baccarani M, Martinelli G. In chronic myeloid leukemia patients on second-line tyrosine kinase inhibitor therapy, deep sequencing of BCR-ABL1 at the time of warning may allow sensitive detection of emerging drug-resistant mutants. BMC Cancer. 2016 Aug 2;16:572. doi: 10.1186/s12885-016-2635-0. PMID 27485109
- BACKGROUNDErnst T, Hoffmann J, Erben P, Hanfstein B, Leitner A, Hehlmann R, Hochhaus A, Muller MC. ABL single nucleotide polymorphisms may masquerade as BCR-ABL mutations associated with resistance to tyrosine kinase inhibitors in patients with chronic myeloid leukemia. Haematologica. 2008 Sep;93(9):1389-93. doi: 10.3324/haematol.12964. Epub 2008 Jul 4. PMID 18603549
- BACKGROUNDCayuela JM, Chomel JC, Coiteux V, Dulucq S, Escoffre-Barbe M, Etancelin P, Etienne G, Hayette S, Millot F, Nibourel O, Nicolini FE, Rea D; pour la France Intergroupe des leucemies myeloides chroniques (Fi-LMC) et le Groupe des biologistes moleculaires des hemopathies malignes (GBMHM). [Recommendations from the French CML Study Group (Fi-LMC) for BCR-ABL1 kinase domain mutation analysis in chronic myeloid leukemia]. Bull Cancer. 2020 Jan;107(1):113-128. doi: 10.1016/j.bulcan.2019.05.011. Epub 2019 Jul 26. French. PMID 31353136