TKI Cessation for Chronic Myeloid Leukemia
(TOKIN Trial)
Trial Summary
What is the purpose of this trial?
This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.
Will I have to stop taking my current medications?
The trial is specifically about stopping tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia, so you will need to stop taking TKIs if you participate. The protocol does not mention other medications, so it's unclear if you need to stop any other current medications.
What data supports the effectiveness of the drug Bosutinib for treating chronic myeloid leukemia?
Research shows that Bosutinib is effective for patients with chronic myeloid leukemia who are resistant or intolerant to previous treatments like Imatinib. In a study, 60% of patients achieved a major cytogenetic response by year 5, and the overall survival rate was 84% at year 5, indicating its effectiveness in managing the disease.12345
Is TKI cessation for chronic myeloid leukemia safe for humans?
How is the TKI cessation treatment for chronic myeloid leukemia unique?
The TKI cessation treatment for chronic myeloid leukemia is unique because it involves stopping the use of tyrosine kinase inhibitors (TKIs) like Bosutinib, Dasatinib, and Imatinib in patients who have achieved a deep molecular response, allowing them to potentially maintain remission without ongoing medication. This approach is different from continuous TKI therapy and offers a treatment-free remission option, which is not common in other cancer treatments.2891011
Eligibility Criteria
This trial is for adults with chronic myeloid leukemia (CML) who have been on TKI therapy for over 3 years and show a stable molecular response. They must have good blood counts, no signs of aggressive leukemia outside the bone marrow, and be expected to live more than a year without treatment. Participants need to understand the study's research nature and consent in writing.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue TKI therapy for more than 36 months with a current status of complete molecular remission (CMR) before cessation
Cessation
Participants stop taking TKI and undergo monthly BCR-ABL1 testing for 24 months
Follow-up
Participants are monitored for progression-free survival and molecular relapse-free survival
Treatment Details
Interventions
- Bosutinib (Tyrosine Kinase Inhibitor)
- Dasatinib (Tyrosine Kinase Inhibitor)
- Imatinib Mesylate (Tyrosine Kinase Inhibitor)
- Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation (Drug)
- Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal (Other)
- Nilotinib (Tyrosine Kinase Inhibitor)
Bosutinib is already approved in United States for the following indications:
- Treatment of adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy
- Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)
- Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML), newly-diagnosed or resistant or intolerant to prior therapy