NCT01460160已完成2 期
A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Bristol-Myers Squibb94 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2012年4月13日最近更新:
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
- 106
- 试验地点
- 94
- 主要终点
- 3-year Event-free Survival (EFS) Rate
研究概览
简要总结
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic 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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL)
- •Age >1 year and < less than 18 years old
- •Induction chemotherapy ≤ 14 days according to institutional standard of care
- •Adequate liver, renal and cardiac function
排除标准
- •Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
- •Extramedullary involvement of the testicles
- •Active systemic bacterial, fungal or viral infection
- •Down syndrome
研究组 & 干预措施
Arm 1: Dasatinib
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
3-year Event-free Survival (EFS) Rate
时间窗: From first dose to 3 years following first dose
3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause
次要结局
- Percentage of Participants Negative for Minimal Residual Disease (MRD)(From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks))
- Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)(From first dose to 3 years or 5 years following first dose)
- Complete Remission Rate(From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks))
- Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse(At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years))
- Number of Participants Experiencing Adverse Events(From first dose to 100 days following last dose (up to approximately 23 months))
研究者
研究点 (94)
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