Stopping Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether patients with chronic myeloid leukemia (CML) can maintain a treatment-free remission after stopping tyrosine kinase inhibitors (TKIs). These medications control the disease by maintaining a very low level, known as molecular remission. The trial aims to determine if patients can remain in remission or regain it without continuous medication. It suits those who have been in molecular remission for at least two years and have taken TKIs for three consecutive years. Participants will stop their medication and undergo regular blood tests to monitor their condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing valuable insights into maintaining remission without medication.
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.
Is there any evidence suggesting that stopping tyrosine kinase inhibitors is likely to be safe for patients with chronic myeloid leukemia?
Research shows that stopping tyrosine kinase inhibitors (TKIs) can be safe for some patients with chronic myeloid leukemia (CML) who are in a deep remission. Studies have found that patients usually tolerate TKIs well. However, only about 30% to 50% of patients qualify to stop these medications.
Long-term reviews indicate that while TKIs work effectively, they can sometimes cause side effects like skin rashes or tiredness, though serious side effects are rare. If the disease returns after stopping TKIs, patients can often resume the medication without major problems.
This trial is in phase 2, indicating that earlier studies have shown some safety, but researchers need more information to confirm this. Patients who have been taking TKIs and are considering stopping them might find this trial helpful in determining if it's a safe choice.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the possibility of stopping tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia patients who are in deep molecular remission. Unlike ongoing treatment with TKIs, this approach aims to see if patients can maintain their remission without continuous medication, which could potentially reduce long-term side effects and improve quality of life. By monitoring patients closely, researchers hope to find out if it's safe to discontinue the drugs while keeping the disease under control. This could mark a significant shift from the standard lifelong treatment approach, offering a glimpse into a more personalized and less burdensome treatment strategy.
What evidence suggests that stopping tyrosine kinase inhibitors might be an effective treatment for chronic myeloid leukemia?
Research has shown that some patients with chronic myeloid leukemia (CML) in the early stage can stop taking tyrosine kinase inhibitors (TKIs) and still control the disease without treatment. This trial will explore this approach by having participants stop taking TKIs and undergo regular monitoring. Studies have found that about 40% to 60% of patients can successfully remain in remission after stopping TKIs. Specifically, one study found that 61% of patients were free from relapse at 6 months, and 50% were relapse-free at 24 months after stopping the medication. These findings suggest that some patients can manage low levels of the disease without ongoing treatment, potentially avoiding the side effects of TKIs. While stopping TKIs doesn't work for everyone, it offers hope for many patients.26789
Who Is on the Research Team?
Sonali Chaudhury
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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