A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study Of Olverembatinib (HQP 1351) In Patients With Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Primary Objective:
To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib.
Secondary Objective:
To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib.
Olverembatinib (HQP 1351)
- RWJBarnabas Health
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Rutgers University
Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age ≥ 18 years old. 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2. 5. Written informed consent obtained prior to any screening procedures. 6. Patients with adequate organ functions Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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