drugset / Trial / NCT05384587

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

NCT05384587

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Asciminib Unknown 80 mg Oral
Subject Asciminib Unknown 200 mg Oral