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RECRUITING
NCT07243483
NA

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

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

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

Interventions

OTHER

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