Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

Phase 2 Active not recruiting 34 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

Timeline

Start: 2022-11-11
Primary completion: 2025-08-13
Completion: 2027-10-17

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper ASC2ESCALATE is an ongoing, Phase II, multicenter, single-arm, dose-escalation study PMID 39387441 ↗

Publications

Atallah EL, Mauro MJ, Sasaki K, Levy MY, Koller P, Yang D, Laine D, Sabo J, Gu E, Cortes JE. Dose-escalation of second-line and first-line asciminib in chronic myeloid leukemia in chronic phase: the ASC2ESCALATE Phase II trial. Future Oncol. 2024;20(38):3065-3075. doi: 10.1080/14796694.2024.2402680. Epub 2024 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asciminib	Unknown	80 mg	Oral
Subject	Asciminib	Unknown	200 mg	Oral