At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓CML-CP diagnosed within 3 months
- ✓Philadelphia chromosome–positive with cytogenetic confirmation
- ✓Meets chronic-phase criteria: <15% blasts, <30% blasts plus promyelocytes, <20% basophils, platelets ≥100×10⁹/L, no extramedullary involvement except hepatosplenomegaly
- ✕Prior CML treatment with chemotherapy, biologic agents, or stem cell transplant (except hydroxyurea/anagrelide); prior TKI use >2 weeks
- ✕CNS infiltration (cytopathologically confirmed)
- ✕QTc prolongation ≥450 ms (males) or ≥460 ms (females) on baseline ECG; cardiac arrhythmias, MI/angina/CABG within 6 months, complete left bundle branch block, high-grade AV block
- ✕Risk factors for Torsades de Pointes (TdP): uncorrected hypokalemia/hypomagnesemia, cardiac failure, symptomatic bradycardia, or concomitant medications with known TdP risk that cannot be discontinued 7 days before study drug
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
In Brief
A Phase 3 clinical trial evaluating Imatinib, Nilotinib, and 3 other interventions for Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive. Active but no longer recruiting, targeting 405 participants across 110 sites in 29 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs
Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food
Interventions
Comes in 100 mg and 400 mg tablets and taken orally
Comes in 150 mg and 200 mg capsules and taken orally
Comes in 100 mg and 400 mg tablets and taken orally
Comes in 20 mg, 50 mg, 70 mg and 100 mg tablets and taken orally
Comes in 40 mg tablets and taken orally