Is There an Association Between Innate CD8+ T Cells and the Evolution of Tyrosine Kinase Inhibito… (NCT04965649) | Clinical Trial Compass
CompletedNot Applicable
Is There an Association Between Innate CD8+ T Cells and the Evolution of Tyrosine Kinase Inhibitor Resistance Mutations in Phi+ Hematological Malignancies.
France30 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is now completed, has any data been published yet showing whether patients with higher levels of innate CD8+ T cells were better able to resist developing TKI resistance mutations — and how might those findings apply to my situation?
2This study was looking at why some patients develop resistance to tyrosine kinase inhibitors like imatinib or dasatinib — does the research suggest there's a way to monitor my own innate CD8+ T cell levels to get an early warning if my treatment might be losing effectiveness?
3The trial focused on Philadelphia chromosome-positive leukemias including CML and Ph+ ALL — given my specific diagnosis, do you think the immune patterns this study was measuring are relevant to how my disease is likely to behave on TKI therapy?
4Because this was an observational study measuring an association rather than testing a new treatment, does anything from its findings change how you'd currently monitor me for TKI resistance, or what testing you'd recommend going forward?
5If it turns out that low innate CD8+ T cell levels are linked to faster development of TKI resistance, are there any clinical trials now open that are building on this kind of research and that might be worth considering in my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of BcrAbl1
Timeframe: 1-6 months after collecting last sample
3
Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of innate CD8+ T cells
Timeframe: 1-6 months after collecting last sample
4
Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:mutated BcrAbl1
Timeframe: 1-6 months after collecting last sample
5
Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of BcrAbl1
Timeframe: 1-6 months after collecting last sample
6
Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of innate CD8+ T cells