Pharmacokinetic dosages of venetoclax: Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 must be affiliated or benificiary of a social security system.
Exclusion Criteria:
* 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
* Any condition that contraindicates blood sampling procedures required by the protocol
* Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and/or woulld likely interfere compliance with study procedures.
* Patient under curatorship, guardianship or judicial protection
* Pregnant or breast-feeding female patient.
Primary outcome measure(s)
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint — From the first day of venetoclax administration to end of the treatment (days) To assess PK exposure parameters : AUC (area under the curve) of venetoclax at steady state
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint — From the first day of venetoclax administration to end of the treatment (days) To assess PK exposure parameters : Minimal Concentration (Cmin) of venetoclax at steady state
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint — From the first day of venetoclax administration to end of the treatment (days) To assess PK exposure parameters : Peak Plasma Concentration (Cmax) of venetoclax at steady state
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint — From the first day of venetoclax administration to end of the treatment (days) To assess PK exposure parameters : Equilibrium concentration (Css) of venetoclax at steady state
Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint — From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure) Proportion of patients with a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) or partial remission (PR) or no remission
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
