Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Major molecular response (MMR) rate at 12 months
研究概览
简要总结
Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
详细描述
The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China.
The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Men or women aged more than or equal to (≥) 18 years.
- •Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0~
- •Signed and dated Informed Consent Form.
排除标准
- •Patients with previously documented T315I mutation.
- •Received BCR-ABL TKI(s) treatment before enrollment.
- •Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
- •Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
- •Pregnant or lactating female.
研究组 & 干预措施
Flumatinib mesylate tablets
干预措施: Flumatinib (Drug)
Imatinib mesylate tablets
干预措施: Imatinib (Drug)
结局指标
主要结局
Major molecular response (MMR) rate at 12 months
时间窗: 12 months
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
次要结局
- MMR rate of high-risk population treated at the end of 12 months(12 months)
- MMR rate at 6, 24 and 36 Months(6, 24 and 36 Months)
- Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months(6, 12, 24 and 36 Months)
- Percentage of participants with transformation-free survival (TFS)(up to 60 Months)
- Percentage of participants with progression free survival (PFS)(up to 60 Months)
- Percentage of participants with overall survival (OS)(up to 60 Months)
- Incidence and severity of adverse events (AE)(From baseline until 28 days after the last dose)