Stopping Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking tyrosine kinase inhibitors (TKIs) if you join this trial, as the study is focused on observing the effects of stopping these medications.
What data supports the effectiveness of stopping the drug Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia?
Research shows that many patients with chronic myeloid leukemia can safely stop taking tyrosine kinase inhibitors if they have achieved a deep and sustained response to the treatment. Studies indicate that a significant number of patients maintain remission without the drug, suggesting that stopping the drug can be effective for some individuals.12345
Is it safe to stop taking tyrosine kinase inhibitors for chronic myeloid leukemia?
Stopping tyrosine kinase inhibitors for chronic myeloid leukemia is generally considered safe for patients who have achieved a deep and sustained response to the treatment. Clinical trials and studies have shown that many patients can successfully stop the medication without their condition worsening, although some may experience side effects like fatigue and diarrhea while on the medication.13456
How is the drug Tyrosine Kinase Inhibitor unique in treating chronic myeloid leukemia?
Tyrosine Kinase Inhibitors are unique because they allow some patients with chronic myeloid leukemia to stop treatment after achieving a deep and sustained molecular response, potentially leading to long-term remission without ongoing medication. This approach differs from traditional treatments that require continuous therapy to manage the disease.12457
What is the purpose of this trial?
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
Research Team
Sonali Chaudhury
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for patients diagnosed with chronic myeloid leukemia in chronic phase (CML-CP) who were under 18 at diagnosis, have been in deep molecular remission for at least 2 years, and have taken tyrosine kinase inhibitors (TKIs) for a minimum of 3 years. Participants must be over the age of 8, able to understand English or Spanish, and not pregnant or breastfeeding. Those with certain genetic mutations or additional chromosomal abnormalities are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Discontinuation
Participants stop taking TKI medication within 10 days after enrollment
Monitoring
Participants undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3
Re-initiation of Treatment
Participants who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3
Follow-up
Participants are followed up annually after completion of study treatment
Treatment Details
Interventions
- Drug Withdrawn
- Tyrosine Kinase Inhibitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator