Trials / Active Not Recruiting
Active Not RecruitingNCT04645706
Innate T Cells and TKI Discontinuation
Innate T-cells as a Biomarker of Successful TKI Arrest in Chronic Myeloid Leukemia
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 92 (actual)
- Sponsor
- Poitiers University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- —
Summary
After more than a decade of treating chronic myeloid leukemia (CML) with tyrosine kinase inhibitors (TKI), the discontinuation of treatment represents the expected new revolution. The investigators has recently discovered a new innate CD8+ T population in healthy subjects, the Eomes+ KIR+ CD8+ T population, with anti-tumor properties. Remarkably, these cells are numerically and functionally deficient in patients at diagnosis and then restored in patients in major molecular remission (MMR) on TKI. Our work performed in a retrospective pilot study interestingly shows a very significant increase in the proportion of CD8+ Eomes+ KIR+ T cells within total T cells in patients with prolonged success in stopping their ITK (≥ 2 years).Thus, the investigators postulate that CD8+ Eomes+ KIR+ T cells are a predictive signature of TKI arrest success in CML. The investigators will rely on a prospective translational study of this cell contingent during treatment cessation.
Detailed description
To perform this research, the investigators have started a prospective translational study to collect samples in CML patients with successful versus patients who have failed TKI therapy discontinuation. The investigators plan to study functional and phenotypic characteristics of innate T cells. The investigators also plan to evaluate in vitro whether immune check points inhibitors could help to restore the innate T lymphocytes population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Characteristics of innate T cells | functional and phenotypic characteristics of innate T cells |
Timeline
- Start date
- 2021-04-20
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2020-11-27
- Last updated
- 2023-08-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04645706. Inclusion in this directory is not an endorsement.