NCT06030089

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Pharmacokinetic sampling	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
OTHER	Vital status determination	Survival situation 12 months after start of treament
OTHER	Toxicity assessments	Toxicity events
DRUG	Venetoclax and azacitidine combination	Response to treatment

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-09-30
• Completion: 2025-03-03
• First posted: 2023-09-08
• Last updated: 2025-12-16

Locations

2 sites across 1 country: France