Pharmacokinetics of Venetoclax in Patients With Chronic Lymphocytic Leukemia

Sponsor
National Taiwan University Hospital
Study ID
NCT04616274
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    This prospective study will draw blood from every patient to measure the venetoclax blood concentration. After blood concentration analysis by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS), the investigator will report the concentration to clinicians.

Study Details

Venetoclax is a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). However, the pharmacokinetic data in Chinese population, as well as the change of venetoclax plasma concentration while taking CYP enzyme inducers or inhibitors, remained unknown so far. Therefore, the aim of this study is to investigate the pharmacokinetic characteristics of venetoclax.

Key Dates

Start date
Jul 1, 2020
Status verified
Oct 2021
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Venetoclax
    Adult CLL patients (≥ 20 year-old) who have already initiated or are going to receive venetoclax treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from July 2020 to December 2025.

Primary Outcome Measure

Area under curve (AUC) of venetoclax in Chinese population [ Time Frame: July 1, 2020 to December 31, 2025 ]

Central Contacts

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