Asciminib for Chronic Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called asciminib for individuals with chronic myeloid leukemia (CML) who are already taking a tyrosine kinase inhibitor (TKI). The researchers aim to determine if adding asciminib can more effectively stop cancer cell growth compared to using the TKI alone. Suitable participants have CML with specific gene markers, have been on nilotinib or dasatinib (types of TKI) for at least two years without recent treatment changes, and have stable but detectable cancer markers. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does require that you continue taking your current tyrosine kinase inhibitor (like nilotinib or dasatinib). If you are on medications that affect the heart's rhythm or certain liver enzymes, you may need to stop them at least one week before starting the trial.
Is there any evidence suggesting that asciminib is likely to be safe for humans?
Research has shown that asciminib is safe for people with chronic myeloid leukemia (CML). In earlier studies, patients using asciminib tolerated it well over a long time without serious side effects.
Another study found that asciminib is safer and easier to tolerate than traditional medications that stop cancer cell growth. This suggests asciminib might be a safer choice for some patients.
In real-life situations, even patients who didn't respond well to other treatments found asciminib effective and safe. After more than eight years of use, it has continued to show strong safety results.
Overall, evidence suggests that asciminib is generally safe and well-tolerated for treating CML.12345Why are researchers excited about this study treatment for chronic myeloid leukemia?
Asciminib is unique because it targets a specific part of the BCR-ABL1 protein, known as the myristoyl pocket, which is different from how current treatments like dasatinib and nilotinib work. This new mechanism of action makes asciminib particularly promising, as it can potentially overcome resistance that some patients develop to existing therapies. Researchers are excited about asciminib because it might offer a more effective treatment option for chronic myeloid leukemia, especially for those who have limited responses to other treatments.
What evidence suggests that asciminib might be an effective treatment for chronic myeloid leukemia?
Research has shown that asciminib holds promise for treating chronic myeloid leukemia (CML). In this trial, participants will receive asciminib alongside standard treatments such as dasatinib or nilotinib. Studies have found that combining asciminib with these standard treatments can greatly improve outcomes. It outperforms other common therapies, leading to a greater reduction in cancer cells, which is a positive sign. Additionally, asciminib tends to cause fewer side effects, potentially making it safer for long-term use. These findings suggest that asciminib could be a strong option for effectively managing CML.13567
Who Is on the Research Team?
Ghayas Issa, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitor therapy for at least 2 years without needing changes in the last 6 months. They must have certain levels of disease markers and normal organ function tests. Pregnant women, those with severe heart conditions or infections like HIV, and anyone with a history of pancreatitis or other active cancers are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive asciminib orally twice daily for up to 36 months while receiving standard of care dasatinib or nilotinib
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term follow-up
Participants are monitored every 3-6 months for long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Asciminib
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator