Tasigna® (Nilotinib) Plus Multi-Agent Chemotherapy for Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 16
- 主要终点
- Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy
研究概览
简要总结
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving nilotinib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving nilotinib together with combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
Primary
- To determine the clinical efficacy of nilotinib and combination chemotherapy, in terms of hematologic and molecular complete remission (CR) rates, in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia or acute mixed lineage leukemia.
Secondary
- To establish the prognostic factors for patients treated with this regimen.
- To determine the duration of CR in patients treated with this regimen.
- To determine the duration of progression-free and overall survival of these patients.
- To determine the toxicity of this regimen in these patients.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nilotinib+mVPD
Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan
干预措施: Nilotinib+mVPD (Drug)
结局指标
主要结局
Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy
时间窗: 1 month
approximate time: at the recovery of cytopenia
次要结局
- Overall Survival(2 years)
- Disease(Relapse)-Free Survival(2 years)
研究者
Kyoo-Hyung Lee
Professor
Asan Medical Center