A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Rate of Major Molecular Response(MMR) by 12 months
研究概览
简要总结
In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
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 with confirmed diagnosis of chronic phase CML within last 3 months
- •Patients with cytogenetically confirmed Ph positive CML in early chronic phase
排除标准
- •Patients with Philadelphia chromosome negative but BCR-ABL positive CML
- •Patients who used imatinib for 8 days or longer before study entry
- •Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
- •Patients with impaired cardiac function
- •Cytologically confirmed CNS involvement
- •Severe or uncontrolled chronic medical condition
- •Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia
- •Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery
研究组 & 干预措施
Imatinib
Imatinib 400mg QD
干预措施: Imatinib (Drug)
Radotinib 600mg
Radotinib 300mg BID
干预措施: Radotinib (Drug)
Radotinib 800mg
Radotinib 400mg BID
干预措施: Radotinib (Drug)
结局指标
主要结局
Rate of Major Molecular Response(MMR) by 12 months
时间窗: 12 months
Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.
次要结局
- Rate of complete cytogenetic response (CCyR) by 12 months(12 months)
- Rate of major molecular response (MMR) at 12 months(12 month)
- Rate of complete molecular response (CMR) by 12 months(12 months)
- Rate of subjects with disease progression(12 months)