This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Myeloid Leukemia

HQP1351CG301

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

2024-05-01

2025-12-01

2026-02-01

Not yet recruiting

Early phase I

285

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part A 2:1 ratio Part B: control', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 285, 'type': 'ESTIMATED'}}

2024-05-21