Clinical Trial

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.
Protocol Amendment History 82 amendments
This ClinicalTrials.gov record has been amended 82 times since 2021-07-12; most recent amendment 2026-06-04.
Status change: Recruiting → Active, Not Recruiting 2023-03-23
Status change: Active, Not Recruiting → Recruiting 2023-03-07
Status change: Recruiting → Active, Not Recruiting 2023-01-20
Status change: Not Yet Recruiting → Recruiting 2021-10-07
Trial Details
NCT Number NCT04971226
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Enrollment 405 participants
Start Date 2021-10-06
Primary Completion 2023-11-28 (estimated)
Study Completion 2031-01-18 (estimated)
Updated on ClinicalTrials.gov 2026-06-08