At a glance
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A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response
In Brief
A Phase 2 clinical trial evaluating Asciminib add-on, Imatinib, and 2 other interventions for CML and 3 related conditions. Completed, enrolled 104 participants across 30 sites in 15 countries.
Detailed Summary
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after the primary analysis to evaluate if asciminib alone could lead to MR4.5 patients in Imatinib for at least one year who have never achieved deep molecular response (DMR).
Study Details
Timeline
Interventions
Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily.
Imatinib was supplied as 400 mg and 100 mg tablets and taken orally once daily.
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules and taken orally twice daily.
Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily (in the fasted state) on a continuous schedule (QD).