An interventional study of Pharmacokinetic sampling and Vital status determination in Acute Myeloid Leukemia, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science
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.
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's enrollment of 20 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion criteria :
Newly diagnosed AML patients
Other: Pharmacokinetic sampling · Other: Vital status determination · Other: Toxicity assessments · Drug: Venetoclax and azacitidine combination
4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2
Survival situation 12 months after start of treament
Toxicity events
Response to treatment
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: Before treatment
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At Day 5 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At Day 9 of 1st round of chemotherapies
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time frame: At 12 months after start of treatment or at relapse whichever comes first
Overall survival
Evaluate the overall survival
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice