Pharmacokinetic dosages of venetoclax
OtherBlood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
NCT Number: NCT07243483
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Centre Hospitalier Pierre Oudot, Bourgoin, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the first day of venetoclax administration and through study completion, at least 24 months
Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and clinical outcome (cytologic response at cycle 6, survival without progression and overall survival).
Time frame: From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration
Correlation between PK exposure parameters (including Cmin, Cmax, Css) of venetoclax and occurence of adverse events grade equal or superior to 3 related to venetoclax/azacitidine and their impact on treatment administration
Time frame: From the first day of ventoclax administration and nd through study completion, at least 24 months
Coefficient of variation of AUC and Cmin at steady state for venetoclax
Time frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between minimal concentration of venetoclax and minimal residual disease
Time frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between Peak Plasma Concentration (Cmax) of venetoclax and minimal residual disease
Time frame: From the first day of venetoclax administration to through the study, at least 24 months
To assess correlation between Equilibrium concentration of venetoclax (Css) and minimal residual disease
Time frame: From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration
Number of patients treated or not treated by an azole antifungal
Contact information is provided by the study sponsor or research team.
Amine Belhabri, MD
CONTACT
Michaël Philippe
CONTACT
Centre Leon Berard
Other
Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)
Acronym: EUREKA-VEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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