NCT04645706Active, not recruiting
Innate T Cells and TKI Discontinuation
Innate T-cells as a Biomarker of Successful TKI Arrest in Chronic Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 4 Aug 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 92 (actual)
- First submitted
- 6 May 2020
- Start date
- 20 Apr 2021
- Primary completion date
- Apr 2028
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT04645706
What you commit to
- Study type: Observational
- Participants enrolled: 92
- From 20 Apr 2021 to the primary completion date, Apr 2028
- 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.
Other
- Refusal to participate in the research
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies
- Patient having stopped treatment for another reason than: deep molecular response of MR4.5 (threshold of 0.0032%) or MR5 (threshold of 0.001%) for at least 2 years
- Translated with www.DeepL.com/Translator (free version)
Who the study is looking for
- Age \> 18 years old
- Diagnosis of CML-PC according to the criteria of the European Leukemia Net (Baccarani et al, 2013)
- Patients treated with TKI for at least 3 years (imatinib, nilotinib, dasatinib, bosutinib, ponatinib)
- Patients meeting the criteria of the French STIM study: deep molecular response of MR4.5 type (threshold of 0.0032%) or MR5 type (threshold of 0.001%) for at least 2 years,
- Free subject, without guardianship or curatorship or subordination
- Patients benefiting from a Social Security system or benefiting from it through a third party
Age in the registry: 18 years to 100 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C.H.U. de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.