Tyrosine Kinase InhibitorNCT05259228
Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia
An observational study of Tyrosine Kinase Inhibitor and Pharmacokinetics, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tyrosine Kinase Inhibitor, Pharmacokinetics, Therapeutic Drug Monitoring
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 20 year-old) who 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.
Who may be able to join
- Adult patients (≥ 20 year-old)
- 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
Who cannot join
- Patients who are unable to cooperate with blood drawing
- Patients who have not submit the informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shu-Wen Lin, MD, 02 - 33668782, shuwenlin@ntu.edu.tw
About this study
Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. The standard treatment, continuous use of tyrosine kinase inhibitors (TKIs), improves 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 as well as 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. Only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs was 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 the 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. The investigators 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 pharmacist-led clinics.
- Keywords
- tyrosine kinase inhibitor, pharmacokinetics, therapeutic drug monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytic methods of TKI plasma concentrations
To develop and validate analytic methods of imatinib, dasatinib, nilotinib and ponatinib plasma concentrations.
Measured: September, 2022 to December, 2025
Minimum plasma concentration [Cmin] of TKI
To measure the minimum plasma concentrations of imatinib, dasatinib, nilotinib and ponatinib.
Measured: September, 2022 to December, 2025
Patient adherence of TKI treatment
To follow up and record the adherence of imatinib, dasatinib, nilotinib and ponatinib of each patient.
Measured: September, 2022 to December, 2025
Analysis of drug-drug interactions
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.
Measured: September, 2022 to December, 2025
Adverse drug reactions and treatment outcomes of TKI
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.
Measured: September, 2022 to December, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tyrosine Kinase InhibitorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Wen Lin, PharmD, MS, Principal investigator, Graduate Institute of Clinical Pharmacy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259228
- Sponsor's protocol ID
- 202008067RIND
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05259228
- Acronym / sponsor ID
- 202008067RIND
- Keywords
- tyrosine kinase inhibitor, pharmacokinetics, therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic myeloid leukemia (CML) consists of 3 clinical stages including chronic phase, accelerated phase and blast crisis. Patients may only survive for few more days to weeks once the disease progresses to blast crisis, even though they might have been stable for several years in the chronic phase. The standard treatment, continuous use of tyrosine kinase inhibitors (TKIs), improves 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 as well as 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. Only 69% of patients followed their physicians' recommendations in a local survey. The medication adherence of TKIs was 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 the 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. The investigators 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 pharmacist-led clinics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 20 year-old) who 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.
Key inclusion criteria (2 listed)
- Adult patients (≥ 20 year-old)
- 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
Key exclusion criteria (2 listed)
- Patients who are unable to cooperate with blood drawing
- Patients who have not submit the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analytic methods of TKI plasma concentrations
Time frame: 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
Time frame: September, 2022 to December, 2025
To measure the minimum plasma concentrations of imatinib, dasatinib, nilotinib and ponatinib.
Patient adherence of TKI treatment
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Wen Lin, PharmD, MS principal investigator
Graduate Institute of Clinical Pharmacy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tyrosine Kinase Inhibitor and Pharmacokinetics, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Wen Lin, PharmD, MS (02 - 33668782, shuwenlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analytic methods of TKI plasma concentrations (time frame: September, 2022 to December, 2025). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.