Overview
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Description
The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.
Eligibility
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.