Asciminib vs Nilotinib for Chronic Myeloid Leukemia
(ASC4START Trial)
Trial Summary
What is the purpose of this trial?
The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot take medications with a known risk of causing heart rhythm problems (Torsades de Pointes) unless they can be safely replaced 7 days before starting the study drug.
What data supports the effectiveness of the drug Nilotinib for treating chronic myeloid leukemia?
Research shows that Nilotinib is effective for patients with chronic myeloid leukemia, especially those who are resistant to or cannot tolerate another drug called imatinib. Studies found that many patients achieved significant improvements, with some maintaining these benefits for up to 48 months.12345
Is asciminib safe for treating chronic myeloid leukemia?
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
Adults (≥18 years) newly diagnosed with Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in chronic phase can join. They must be within 3 months of diagnosis, have an ECOG performance status of 0 or 1, and proper organ function. Excluded are those previously treated for CML (except hydroxyurea/anagrelide), with certain heart conditions, severe concurrent diseases, recent major surgery, other active malignancies within the past 3 years (some exceptions apply), a history of pancreatitis or liver disease, and known HIV/HBV/HCV infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either asciminib 80 mg QD or nilotinib 300 mg BID until unacceptable toxicity, disease progression, or at the discretion of the investigator or participants
Follow-up
A safety follow-up visit/call is performed approximately 30 days after the end of treatment. Participants who discontinue treatment prematurely are followed up for survival and progression
Long-term follow-up
Participants are monitored for survival and progression to Accelerated Phase/Blast Crisis up until the end of the study
Treatment Details
Interventions
- Asciminib
- Nilotinib
Asciminib is already approved in United States, European Union for the following indications:
- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
- Ph+ CML in CP with the T315I mutation
- newly diagnosed Ph+ CML in CP
- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
- Ph+ CML in CP with the T315I mutation
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