Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase

This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.

NCT Number	NCT05143840
Lead Sponsor	University of Alabama at Birmingham Collaborators: H. Jean Khoury Cure CML Consortium
Conditions	Chronic Myeloid Leukemia, Chronic Phase, Adult CML, Leukemia, Myeloid, Leukemia,Myeloid, Chronic
Enrollment	100 participants
Start Date	2022-04-22
Primary Completion	2032-02 (estimated)
Study Completion	2032-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-22