The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in Patients With Chronic Myeloid Leukemia in Chronic Phase: an Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.
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
- •Age ≥ 18 years;
- •Diagnosis of CML-CP with Ph+;
- •ECOG 0, 1, or 2;
- •Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months;
- •Ability to provide written informed consent prior to any study related screening procedures being done
排除标准
- •Previously documented T315I mutation;
- •Previous treatment with any other tyrosine kinase inhibitor except for imatinib;
- •Prior accelerated phase or blast phase CML;
- •Loss of CHR or cytogenetic response
研究组 & 干预措施
Flumatinib
600mg QD orally form 1 to 12 months
干预措施: Flumatinib (Drug)
Dasatinib
100mg QD orally form 1 to 12 months
干预措施: Dasatinib (Drug)
结局指标
主要结局
Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.
时间窗: 3 months
次要结局
- Time to optimal imatinib-related adverse event improvement.(12 months)
- Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.(12 months)