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Venetoclax

Azacitidine

Antimetabolites

Enzyme Inhibitors

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

Pharmacokinetic sampling

Survival situation 12 months after start of treament

Vital status determination

Toxicity assessments

Venetoclax and azacitidine combination

Thomas Cluzeau, Pr

Valérie FOUSSAT

Geoffroy Venton, MD

Thomas Cluzeau

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.

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

Correlation of VEN plasma levels with inhibition of its Bcl-2 target

Centre Hospitalier Universitaire de Nice

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven	NCT06030089	Acute Myeloid L...	Pharmacokinetic... Vital status de... Toxicity assess... Venetoclax and ...	18 Years -	Centre Hospitalier Universitaire de Nice
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven	NCT06030089	Acute Myeloid L...	Pharmacokinetic... Vital status de... Toxicity assess... Venetoclax and ...	18 Years -	Centre Hospitalier Universitaire de Nice

Spots Global Cancer Trial Database for venetoclax and azacitidine combination