Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacokinetic sampling | Other | — | UNRESOLVED |
| Toxicity assessments | Other | — | UNRESOLVED |
| Venetoclax and azacitidine combination | Drug | — | UNRESOLVED |
| Vital status determination | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
- description
- Newly diagnosed AML patients
- interventionNames
- Other: Pharmacokinetic sampling
- Other: Vital status determination
- Other: Toxicity assessments
- Drug: Venetoclax and azacitidine combination
Primary outcomes (4)
- measure
- Plasmatic dosage
- timeFrame
- Before treatment
- description
- Correlation of VEN plasma levels with inhibition of its Bcl-2 target
- measure
- Plasmatic dosage
- timeFrame
- At Day 5 of 1st round of chemotherapies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : * 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 Exclusion criteria : * Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4 * Presence of an active, uncontrolled infection * Patient participating or having participated in a clinical drug trial in the month prior to inclusion. * Vulnerable persons
References
Publications (0)
Data not yet available