A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 333
- 试验地点
- 18
- 主要终点
- Part A: Randomized Controlled Arms: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
研究概览
简要总结
This is a global, multi-center, open-label randomized and registrational phase 3 study of olverembatinib comprised of two parts: Part A and Part B. Part A is a 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 tyrosine kinase inhibitors (TKIs). Part B is a single arm cohort to evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously treated with at least 1 TKI and without other available effective treatment options.
Number of Subjects: A total of 285 patients will be randomized in a 2:1 ratio to either olverembatinib (n=190) or bosutinib (n=95) arm in Part A. In addition, 48 patients with T315I mutation will be enrolled in Part B.
Part A
Olverembatinib is administered orally, 30 mg, once every other day (QOD) with food. Consider dose escalation to 40 mg QOD in patients who are currently taking 30 mg QOD, do not have olverembatinib-related Grade 3 or higher adverse events and who:
• have not achieved complete hematological response (CHR) by week 8, or
• have not achieved MMR by week 12.
Part B
Olverembatinib is administered orally, 40 mg, QOD with food.
Total duration of study: 5-8 years, approximately 2 years for recruiting.
Duration of treatment:
There is no fixed duration of treatment projected for each patient. Patients are treated in the study up to the end of study treatment period, which is defined as up to 96 weeks after the last patient receives the first dose, unless patients have discontinued treatment earlier. Patients may be discontinued from treatment with study drug at any time due to unacceptable toxicity, disease progression and/or at the discretion of the investigator or the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study must meet all of the following criteria.
- •1 Age 18 years or above.
- •2 Diagnosis of CML-CP 3 Part A: Previously treated with at least two approved TKIs Part B: with T315I mutation at screening.
- •4 Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to
- •5 Written informed consent obtained prior to any screening procedures.
- •6 Patients with adequate organ functions.
排除标准
- •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.
结局指标
主要结局
Part A: Randomized Controlled Arms: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
时间窗: 24 weeks
Part B: Single Arm: To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation
时间窗: 24 weeks
次要结局
- Part A: Randomized Controlled Arms: To compare the MMR rate at 96 weeks of olverembatinib versus bosutinib(Part B: Single Arm: To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutation)
- Part A: Randomized Controlled Arms(Other Secondary Objectives)
- Part B: Single Arm(Other Secondary Objectives)