Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia
Study Details
Study Description
Brief Summary
Chronic myeloid leukemia (CML) consists with 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progress es to blast crisis even though they might have been stable for several years on chronic phase. The standard treatment continuous use of tyrosine kinase inhibitors (TKIs), improve the long term survival, and even may help patients achieve complete remission Four TKIs are reimbursed by National Health Insurance in Taiwan. Among them, imatinib, nilotinib and dasatinib, and ponatinib are the first, second and third generations of TKIs, respectively. Many factors influence the disease control of CML, such as TKI type, genetic mutation and medication adherence. There were only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs were compromised based on several clinical studies domestically and worldwide due to the slow progression in the chronic phase. Patients might hold or decrease the dose of TKIs on their own when they suffer side effects. Furthermore, the significant intra subject variations of TKI plasma concentration and drug drug and drug food interactions which alter metabolism of TKIs may lessen therapeutic effect and patient safety. Therefore, this study aims to develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations. We plan to build the pharmacokinetic models of these 4 TKIs and analyze the impacts of meals, adherence, hepatic enzyme inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers, etc. Adverse drug reactions and treatment outcomes will be evaluated to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacistled clinics.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Analytic methods of TKI plasma concentrations [September, 2022 to December, 2025]
To develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations.
- Minimum plasma concentration [Cmin] of TKI [September, 2022 to December, 2025]
To measure the minimum plasma concentrations of imatinib, dasatinib, nilotinib and ponatinib.
- Patient adherence of TKI treatment [September, 2022 to December, 2025]
To follow up and record the adherence of imatinib, dasatinib, nilotinib and ponatinib of each patient.
- Analysis of drug-drug interactions [September, 2022 to December, 2025]
To analyze the impacts of hepatic enzyme (CYP) inhibitors and inducers, antacids, proton pump inhibitors and H2 blockers on the concentration of imatinib, dasatinib, nilotinib and ponatinib.
- Adverse drug reactions and treatment outcomes of TKI [September, 2022 to December, 2025]
To evaluate the adverse drug reactions and treatment outcomes in order to determine the availability and feasibility of therapeutic drug monitoring of TKIs as part of routine service in pharmacist-led clinics.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (≥ 20 year-old)
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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:
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Patients who are unable to cooperate with blood drawing
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Patients who have not submit the informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Shu-Wen Lin, PharmD, MS, Graduate Institute of Clinical Pharmacy, National Taiwan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202008067RIND