NCT06423911 · Ascentage Pharma Group Inc.
Study of Olverembatinib (HQP1351) in Patients With CP-CML
(POLARIS-2)
What this study is about
A Global conducted at multiple hospitals, Open Label, randomly assigned, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
View original scientific description
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Patients eligible for this study must not meet any of the following criteria.
- For Part A only: T315I mutation at any time prior to starting study treatment.
- Active infection that requires systemic drug therapy
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
- Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
- Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
- Pregnant or nursing (lactating) women.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2025 · Source of record for eligibility and locations