NCT06030089Completed
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven
Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 18 Aug 2023
- Start date
- 26 Feb 2024
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06030089
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 26 Feb 2024 to the primary completion date, 30 Sept 2024
- 2 sites 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.
Prior treatment
- Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
- Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
Other illness
- Presence of an active, uncontrolled infection
Other
- Vulnerable persons
Who the study is looking for
- Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
- Patients aged 18 or over
- Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
- Patient having signed the study informed consent form
- Patient with social security coverage
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital la Conception Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.