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


Study Number
2944822
Phase
II
Age Group
Adult
Purpose

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.

Full Title

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

ClinicalTrials.Gov ID
NCT05143840

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.