Clinical Trials /

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

NCT02269267

Description:

This is a non-randomized, prospective, single-group longitudinal study. The purpose of this study is to improve the decision making process used by physicians and patients when they are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

Title

  • Brief Title: The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
  • Official Title: The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)
  • Clinical Trial IDs

    NCT ID: NCT02269267

    ORG ID: PRO00023447

    Trial Conditions

    Leukemia, Myeloid, Chronic

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a non-randomized, prospective, single-group longitudinal study. The purpose of this
    study is to improve the decision making process used by physicians and patients when they
    are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.

    Detailed Description

    This is a non-randomized, prospective, single-group longitudinal study. The overall
    objective is to improve decision making for TKI discontinuation in eligible CML patients.
    Patients with CML who are on imatinib, dasatinib, nilotinib, or bosutinib and have had
    undetectable BCR-ABL by PCR for at least 2 years will stop their TKI. The study will closely
    monitor patients using standard RQ-PCR testing for molecular recurrence, testing them
    monthly for 6 months, then every other month until 24 months, and then quarterly until 36
    months. Concurrently, the study will assess a wide range of patient reported outcomes (PROs)
    before stopping TKIs and after discontinuation in conjunction with PCR testing, though at
    fewer time points. Patients who have molecular CML recurrence based on RQ-PCR will restart
    imatinib, dasatinib, nilotinib, or bosutinib and will continue to be monitored for disease
    status and patient-reported health status until the end of the study.

    Trial Arms

    Name Type Description Interventions
    Discontinuation of TKI medication Other Patients with CML patients who are on imatinib, dasatinib, nilotinib, or bosutinib and have had undetectable BCR-ABL by PCR for at least 2 years will stop their TKI.

    Eligibility Criteria

    Inclusion Criteria:

    1. Age 18 or older at time of study entry

    2. Able to speak and read English

    3. Willing and able to give informed consent

    4. Diagnosed with CML in chronic phase

    5. Currently taking imatinib, dasatinib, nilotinib or bosutinib

    6. Patient has been on TKI therapy for at least 3 years

    7. Documented undetectable BCR-ABL by PCR for at least 2 years according to the
    patient's local lab

    8. Undetectable PCR at least 3 times prior to screening according to the patient's local
    lab

    9. Two (2) Screening PCRs have been completed and both results are < MR4.5 by central
    lab

    10. Has been on any number of TKIs, but has not been resistant to any TKI (i.e. changes
    made for intolerance are allowed)

    11. Patient has been compliant with therapy per treating physician

    Exclusion Criteria:

    1. Prior hematopoietic stem cell transplantation

    2. Poor compliance with taking TKI

    3. Unable to follow lab appointments schedule

    4. Life expectancy less than 36 months

    5. Patients who have been resistant to previous TKI therapy are not eligible

    6. Pregnant or lactating women

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Proportion of patients with CML who develop molecular recurrence after discontinuing TKIs

    Patient-reported health status of patients before and after stopping TKIs

    Secondary Outcome Measures

    Trial Keywords