This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
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⁃ Patients eligible for inclusion in this study must meet all of the following criteria.
• Age ≥ 18 years old.
• Diagnosis of CML-CP
• Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• Written informed consent obtained prior to any screening procedures.
• Patients with adequate organ functions
Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Kate Shantz
kate.shantz@ascentage.com
301-509-0038
Backup
Huanshan Guo
huanshan.guo@ascentage.com
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2026-02
Participants
Target number of participants: 285
Treatments
Other: Part A, RCT, olverembatinib arm and bosutinib arm
Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs
Other: Part B, SAT, olverembatinib arm
To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
Related Therapeutic Areas
Sponsors
Leads: Ascentage Pharma Group Inc.