Investigating how venetoclax behaves in the body for CLL patients
Pharmacokinetics of Venetoclax in Patients With Chronic Lymphocytic Leukemia
This study looks at how venetoclax works in the body of adults with chronic lymphocytic leukemia (CLL) to see how diet and other medications might change its effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04616274 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the pharmacokinetics of venetoclax in adult patients diagnosed with chronic lymphocytic leukemia (CLL) at the National Taiwan University Hospital. It focuses on understanding how factors such as dietary fat content and the use of CYP3A enzyme inducers or inhibitors affect the plasma concentration of venetoclax. The study will include patients who have already started or are about to begin venetoclax treatment, providing valuable data on its efficacy and safety in the Asian population. The findings could help optimize treatment protocols for CLL patients in this demographic.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 20 and older with a diagnosis of chronic lymphocytic leukemia who are receiving or will receive venetoclax treatment.
Not a fit: Patients unable to cooperate with blood drawing or who have not submitted informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for CLL patients, particularly in the Asian population.
How similar studies have performed: While pharmacokinetic studies of venetoclax have been conducted, this specific focus on the Asian population and the influence of dietary and drug interactions is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 20 year-old) with diagnosis of chronic lymphocytic leukemia * Patients who meet the above criteria and 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 Exclusion Criteria: * Patients who are unable to cooperate with blood drawing * Patients who have not submit the informed consent
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shu-Wen Lin, Pharm.D
- Email: shuwenlin@ntu.edu.tw
- Phone: 886-2-33668782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.