Global Phase 3 Study Comparing Olverembatinib and Bosutinib in Adults With Chronic Phase Chronic Myeloid Leukemia

What this Trial Is About

This research aims to evaluate the effects of olverembatinib HQP1351 in patients with chronic phase chronic myeloid leukemia CML-CP. The study is a global, multicenter, open-label, randomized Phase 3 trial sponsored by Ascentage Pharma Group Inc. It focuses on patients previously treated with at least two tyrosine kinase inhibitors TKIs and includes those with and without the T315I mutation. The goal is to compare olverembatinib with bosutinib in patients without the mutation and assess olverembatinibs benefits in those with the mutation. The study includes two parts Part A is a randomized controlled trial comparing olverembatinib taken every other day to bosutinib taken daily in CML-CP patients without the T315I mutation. Part B is a single-arm trial evaluating olverembatinib in patients with the T315I mutation. Treatment schedules and doses are based on these regimens, and the study evaluates efficacy and safety over time. Participants will be monitored for molecular response rates at 24 weeks in both parts of the study. Researchers will assess safety, organ function, and performance status. Informed consent and adequate organ function are required, and participants will undergo regular clinical evaluations to measure outcomes and monitor for side effects. The study is expected to continue until February 2026, with ongoing safety and efficacy assessments throughout participation.

Study of Olverembatinib (HQP1351) in Patients With CP-CML