Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05259228
Collaborator
(none)
40
1
39
1

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitor in Patients With Chronic Myeloid Leukemia
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Minimum plasma concentration [Cmin] of TKI [September, 2022 to December, 2025]

      To measure the minimum plasma concentrations of imatinib, dasatinib, nilotinib and ponatinib.

    3. 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.

    4. 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.

    5. 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

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05259228
    Other Study ID Numbers:
    • 202008067RIND
    First Posted:
    Feb 28, 2022
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2022