At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 199 enrolled
Drug / intervention
ABL001 40mg BID +2 moredrug
Likely dose
ABL001 40mg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Multi-center, Open-label, Treatment Optimization Study of Oral Asciminib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Previously Treated With 2 or More Tyrosine Kinase Inhibitors
In Brief
A Phase 3 clinical trial evaluating ABL001 40mg BID, ABL001 80mg QD, and 1 other intervention for Chronic Myelogenous Leukemia. Completed, enrolled 199 participants across 48 sites in 16 countries.
Detailed Summary
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesArgentina, Austria, Brazil, Canada, France, Germany, Greece, Italy, Malaysia, Oman, Poland, Singapore, South Korea, Spain, United Kingdom, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartOct 2021
Primary CompletionMar 2024
Study CompletionFeb 2026
TodayJul 2026
First PostedJul 1, 2021
Enrollment StartOct 13, 2021
Primary CompletionMar 12, 2024
Study CompletionFeb 25, 2026
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.0 years ago
Interventions
ABL001 40mg BIDdrug
One tablet of 40 mg will be taken orally twice a day (BID)
ABL001 80mg QDdrug
Two tablets of 40 mg will be taken orally once a day (QD)
ABL001 200mg QDdrug
Five tablets of 40 mg will be taken orally once a day (QD)