A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 333
- 试验地点
- 164
- 主要终点
- MMR rate Part A
研究概览
简要总结
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).
Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient has adequate organ function
排除标准
- •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
研究组 & 干预措施
Part A, RCT, olverembatinib arm and bosutinib arm
Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs
干预措施: olverembatinib (Drug)
Part A, RCT, olverembatinib arm and bosutinib arm
Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs
干预措施: Bosutinib (Drug)
Part B, SAT, olverembatinib arm
To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously
干预措施: olverembatinib (Drug)
结局指标
主要结局
MMR rate Part A
时间窗: 24 weeks
To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
MMR rate Part B
时间窗: 24 weeks
To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation
24-Week MMR Rate (Part A)
时间窗: 24 weeks
To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib
24-Week MMR Rate (Part B)
时间窗: 24 weeks
To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation
次要结局
- 96-Week MMR Rate (Part A)(96 weeks)
- 96-Week MMR Rate (Part B)(96 weeks)
- Cytogenic Response Rate (Part A)(Through 96 weeks (i.e., at 24, 48, and 96 weeks))
- Cytogenic Response Rate (Part B)(Through 96 weeks (i.e., at 24, 48, and 96 weeks))
- Progression Free Survival (PFS) (Part A)(5 years after the last patient received the first study dose)
- Progression Free Survival (PFS) (Part B)(5 years after the last patient received the first study dose)
- Overall Survival (OS) (Part A)(5 years after the last patient received the first study dose)
- Overall Survival (OS) (Part B)(5 years after the last patient received the first study dose)
- Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)(96 weeks after the last patient received the first study dose)
- Characterization of population pharmacokinetics of olverembatinib (Parts A and B)(At the end of Cycle 1 and Cycle 2 (each cycle is 28 days))