NCT01464411Unknown不适用
Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Kanto CML Study Group1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 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 effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- •20 years old over
- •ECOG performance status (PS) score 0-2
- •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 whithin 6 months
- •have an Angina within 3 months
- •have a Congestive heart failure within 3 months
- •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
结局指标
主要结局
Rate of complete molecular response (CMR) after treatment with dasatinib
时间窗: by 18 months
The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.
次要结局
- Complete Cytogenetic Response(CCyR)(by 6,12 months)
- Expansions rate of large granular lymphocyte(by 12 months)
- Progression free survival(at 36 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(by 36 months)
- complete molecular response (CMR)(by 3,6,12,24, 36 months)
- Major Molecular Response(MMR)(by 3,6,12,18,24,36 months)
研究者
Takashi Kumagai
M.D, Ph.D
Kanto CML Study Group
研究点 (1)
Loading locations...
相似试验
已完成
2 期
First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALLAcute Lymphoblastic LeukemiaNCT01004497The Catholic University of Korea51
已完成
2 期
Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal CancerRecurrent Colon CancerRecurrent Rectal CancerStage IV Colon CancerStage IV Rectal CancerNCT00504153National Cancer Institute (NCI)19
已完成
1 期
A Phase I/II Study of Dasatinib and DacarbazineMetastatic MelanomaNCT00597038H. Lee Moffitt Cancer Center and Research Institute50
已完成
2 期
A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast CancerMetastasisBreast CancerNCT00371254Bristol-Myers Squibb55
已完成
2 期
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast CancerMetastasisBreast CancerNCT00371345Bristol-Myers Squibb92