NCT01247493已完成2 期
Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Complete remission rate
研究概览
简要总结
A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously untreated AML (excluding acute promyelocytic leukemia)
- •age greater than 60 years old
- •ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2
- •adequate hepatic/ renal/ cardiac function
排除标准
- •acute promyelocytic leukemia
- •significant cardiac disease
- •combined non-hematologic malignancy
- •aleukemic leukemia (only granulocytic sarcoma)
- •CNS (Central Nervous system) involvement
- •significant comorbidity/ uncontrollable bleeding tendency
结局指标
主要结局
Complete remission rate
Rate of complete remssion (CR) after two cycles of m-FLAI induction
次要结局
- Rate of serious adverse events (SAE)
- Event Free Survival
- overall survival
- Predictive factors for Complete remission
研究者
研究点 (2)
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