NCT01342679已完成2 期
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Kanto CML Study Group1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Rate of complete molecular response (CMR) after treatment with dasatinib
研究概览
简要总结
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Myeloid Leukemia in the Chronic Phase
- •20 years old over
- •ECOG performance status (PS) score 0-2
- •Patients for major molecular response (MMR) with no CMR
- •Adequate organ function (hepatic, renal and lung)
- •Signed written informed consent
排除标准
- •A case with the double cancer of the activity
- •Women who are pregnant or breastfeeding
- •The case of Pleural effusion clearly
- •Patients with complications or a history of severe or uncontrolled cardiovascular failure following
- •have a Myocardial infarction within 6 months
- •have an Angina within 3 months
- •have a Congestive heart failure within 3 months
- •have a suspected congenital QT syndrome
- •have a QTc interval of more than 450msec at baseline
- •A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
- •Prior treatment with dasatinib
- •Subjects with T315I, F317L and V299L BCR-ABL point mutations
研究组 & 干预措施
dasatinib
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
Rate of complete molecular response (CMR) after treatment with dasatinib
时间窗: at 12 months
次要结局
- Dasatinib of dose intensity(at 12 months)
- Expansions rate of large granular lymphocyte(at 12 months)
- Progression free survival(at 12 months)
- Number of Participants with Adverse Events(at 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A study on organ protection during bypass sugery by inflating a bloodpressure cuff on the arm.CABG, remote preconditioning, cardioprotectionNL-OMON21859Academical Medical Centre, University of Amsterdam56
已完成
不适用
Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal CancerColorectal CancerNCT00984048Jewish General Hospital160
已完成
不适用
Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer PatientsTriple Negative Breast CancerNCT01276899Jewish General Hospital80
已完成
不适用
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 PandemicCOVIDRT-ddPCR MultiplexNCT04367545University Hospital, Rouen130
Unknown
不适用
Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in ChinaBreast CancerNCT03792529Peking University Cancer Hospital & Institute300