NCT04155411Unknown4 期
Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)
Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
详细描述
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
- •ECOG performance of 0-
- •Adequate end organ function defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- •Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
排除标准
- •History of any TKI treatments.
- •History of Pulmonary arterial hypertension and Pleural effusion
- •NYHA cardiac class 3-4 heart disease.
- •Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
- •Uncontrolled angina within 12 months.
- •Diagnosed or suspected congenital long QT syndrome.
- •Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
- •Prolonged QTc interval on pre-entry electrocardiogram (>450 msec).
- •Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
- •Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized.
- •Pregnant or breast-feeding women are excluded.
- •Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.
研究组 & 干预措施
Dasatinib 70 mg
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
时间窗: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
次要结局
- Proportion of patients with MR 4.0 at 12 months.(12 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib(18 months)
- Proportion of patients with MR 4.5 at 12 months.(12 months)
- Proportion of patients with Complete cytogenetic response (CCyR) at 12 months(12 months)
研究者
研究点 (1)
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