Study of Venetoclax Pharmacokinetics and Pharmacodynamics in Adults With Acute Myeloid Leukemia Starting First-Line Treatment

What this Trial Is About

Researchers are studying the relationship between how the body processes venetoclax pharmacokinetics and how the drug affects patients pharmacodynamics with Acute Myeloid Leukemia AML. This prospective, multicenter clinical-biological cohort study aims to better understand venetoclaxs effects in patients starting treatment for AML. The study involves minimal risks related to blood sample collection and does not change participants therapeutic management. The study includes blood samples taken for pharmacokinetic dosing of venetoclax at different points during the treatment period. Up to 21 samples may be collected, with a maximum of 12 mL of blood per sampling day. Patients included will be those starting venetoclax-azacitidine as first-line treatment, with no triple targeted therapy combinations allowed. Participants will provide blood samples for pharmacokinetic testing and clinical data collection from the first day of venetoclax administration through treatment and follow-up periods. Researchers will measure the best pharmacokinetic indicators of treatment response and assess the relationship between venetoclax exposure and clinical outcomes or adverse events. The study plans follow-up for at least 24 months to observe variability in drug exposure and effects.

Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia