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Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia
Sponsor: Centre Leon Berard
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.
Official title: Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01-21
Completion Date
2029-01-01
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Pharmacokinetic dosages of venetoclax
Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period
Locations (4)
CHU de Grenoble
Grenoble, France
Centre Leon Berard
Lyon, France
CHU de Saint-Étienne
Saint-Etienne, France
Hôpitaux Nord-Ouest - Villefranche-sur-Saône
Villefranche-sur-Saône, France