Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
Status:
Not yet recruiting
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
Summary
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 orally twice daily. Response is
determined by PCR (polymerase chain reaction) blood test during the study. Patients who have
not achieved a response after 24 months of single agent asciminib will be offered the
addition of nilotinib. Nilotinib will be started at 300 mg BID in addition to asciminib if
indicated. Patients will discontinue study treatment if they experience disease progression,
or unacceptable toxicity.