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

未提供0 个研究点目标入组 333 人开始时间: 待定

试验速览

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•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 and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
•Patients with adequate organ functions

•Patients eligible for this study must not meet any of the following criteria.
•For Part A only: T315I or V299L 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.

发起方

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