Monitoring drug levels in chronic myeloid leukemia patients using tyrosine kinase inhibitors
Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia
This study is testing how well different medications for chronic myeloid leukemia work in patients to help improve their treatment and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | imatinib, dasatinib, nilotinib, ponatinib |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05259228 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with chronic myeloid leukemia (CML) who are being treated with tyrosine kinase inhibitors (TKIs) such as imatinib, nilotinib, dasatinib, or ponatinib. The study aims to monitor the pharmacokinetics of these drugs to improve medication adherence and disease control. By analyzing factors that influence treatment outcomes, the research seeks to enhance long-term survival rates and potentially achieve complete remission in patients. The study will take place at the National Taiwan University Hospital from September 2022 to December 2025.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 20 and older who are receiving or will receive TKI treatment at the National Taiwan University Hospital.
Not a fit: Patients who are unable to cooperate with blood drawing or have not submitted informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for patients with chronic myeloid leukemia through better adherence to TKI therapy.
How similar studies have performed: Other studies have shown success in therapeutic drug monitoring for TKIs, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥ 20 year-old) 2. Patients who meet the above criteria and have already initiated or are going to receive imatinib, dasatinib, nilotinib, or ponatinib treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from September 2022 to December 2025 Exclusion Criteria: 1. Patients who are unable to cooperate with blood drawing 2. Patients who have not submit the informed consent
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shu-Wen Lin, PharmD, MS — Graduate Institute of Clinical Pharmacy, National Taiwan University
- Study coordinator: Shu-Wen Lin, PharmD, MS
- Email: shuwenlin@ntu.edu.tw
- Phone: 02 - 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.