Clinical Trial

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

Study acronym: ASC4START
Active, Not Recruiting Phase 3
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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).
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-05-28
Trial Details
NCT Number NCT05456191
Lead Sponsor Novartis Pharmaceuticals
Conditions Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Enrollment 568 participants
Start Date 2022-11-21
Primary Completion 2025-05-15 (estimated)
Study Completion 2031-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-27