Asciminib vs Nilotinib for Chronic Myeloid Leukemia (ASC4START Trial)

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4,5 years.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two drugs to treat newly diagnosed Chronic Myelogenous Leukemia in Chronic Phase.

Who is the study for?

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.

What is being tested?

The trial is testing the tolerability and effectiveness of two oral drugs: Asciminib versus Nilotinib in adults with newly diagnosed Ph+ CML-CP. Participants will receive one drug or the other to compare how well they tolerate them and how effective they are at treating their leukemia.

What are the potential side effects?

Potential side effects for both Asciminib and Nilotinib include nausea, rash, fatigue, headaches, muscle pain; however specific side effects may vary between drugs. Heart problems like abnormal heartbeat could occur especially if there's a history of cardiac issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4.5 years. for reporting.