At a glance
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A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.
In Brief
A Phase 3 clinical trial evaluating Asciminib and Nilotinib for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia. Active but no longer recruiting, targeting 568 participants across 120 sites in 24 countries.
Detailed Summary
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Study Details
Timeline
Interventions
Asciminib 80 mg QD administered under fasting conditions.
Nilotinib 300 mg twice a day (BID) was administered under fasting conditions.