At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 56 enrolled
Drug / intervention
ABL001drug
Likely dose
ABL001 20 mgfrom 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.
An Open Label, Multi-center Phase IIIb Study of Asciminib (ABL001) Monotherapy in Previously Treated Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
In Brief
A Phase 3 clinical trial evaluating ABL001 for Chronic Myelogenous Leukemia - Chronic Phase. Completed, enrolled 56 participants across 26 sites.
Detailed Summary
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartMay 2021
Primary CompletionJun 2023
Study CompletionJun 2024
TodayJul 2026
First PostedDec 14, 2020
Enrollment StartMay 25, 2021
Primary CompletionJun 20, 2023
Study CompletionJun 26, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.5 years ago
Interventions
ABL001drug
Asciminib will be supplied as 20 mg or 40 mg strength tablets will be administered orally in accordance with the assigned cohort.