This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML).
This study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.
Male or female patient aged of at least 18 years on day of signing informed consent
Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)
Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized
Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
Patient with acute promyelocytic leukemia (APL, AML3)
Patient with AML eligible to intensive chemotherapy
Patient previously treaed with venetoclax and/or azacitidine
Patient participating to another clinical trial with a medicinal product
Centre Leon Berard
Lead sponsor
Fédération Leucémie Espoir
Collaborator