Spots Global Cancer Trial Database for Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

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Trial Identification

Brief Title: Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

Official Title: 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

Study ID: NCT06030089

Conditions

Acute Myeloid Leukemia

Interventions

Pharmacokinetic sampling

Vital status determination

Toxicity assessments

Venetoclax and azacitidine combination

Study Description

Brief 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.

Detailed Description: