Asciminib for Chronic Myelogenous Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves patients who have been treated with Tyrosine Kinase Inhibitors (TKIs), it might be necessary to discuss your current medications with the study team.
Is asciminib safe for humans?
Asciminib has been studied in clinical trials for chronic myeloid leukemia and is generally considered safe, with common side effects including low blood platelet levels (thrombocytopenia), low white blood cell levels (neutropenia), and increased pancreatic enzymes. Most side effects were mild to moderate, and the likelihood of new side effects decreased over time.12345
How is the drug Asciminib unique in treating chronic myelogenous leukemia?
Asciminib is unique because it is the first drug to specifically target the ABL myristoyl pocket, a different site on the BCR-ABL1 protein than other treatments, making it effective against certain resistant forms of chronic myelogenous leukemia. It is taken orally and has shown better safety and efficacy compared to some existing treatments.12346
What data supports the effectiveness of the drug Asciminib for treating chronic myelogenous leukemia?
Research shows that Asciminib is effective for patients with chronic myeloid leukemia who have been treated with at least two other drugs, as it has a higher response rate and fewer side effects compared to another drug, bosutinib. It is also effective for patients with a specific mutation (T315I) that makes them resistant to other treatments.23467
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with chronic myelogenous leukemia in chronic phase (CML-CP) who have tried at least two Tyrosine Kinase Inhibitors without success or cannot tolerate them. They must not have had a stem-cell transplant, plan to undergo one soon, or have certain heart conditions or severe medical issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive asciminib continuously for up to 144 weeks or until disease progression, treatment failure, or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Asciminib
Asciminib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD