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Study of Olverembatinib (HQP1351) in Patients With CP-CML
Trial Status: active
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of
Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia
(POLARIS-2)
Inclusion Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06423911.