NCT01721876已完成3 期
A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 666
- 试验地点
- 122
- 主要终点
- Objective Response (OR)
研究概览
简要总结
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 65 Years 至 —（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
Volasertib and Cytarabine
Experimental
干预措施: Volasertib (Drug)
Volasertib and Cytarabine
Experimental
干预措施: Cytarabine (Drug)
Placebo and Cytarabine
Placebo Comparator
干预措施: Placebo (Drug)
Placebo and Cytarabine
Placebo Comparator
干预措施: Cytarabine (Drug)
结局指标
主要结局
Objective Response (OR)
时间窗: Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.
OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.
次要结局
- Overall Survival (OS)(From randomization until death due to any cause, up to 1557 days.)
- Event-free Survival (EFS)(From randomization until disease progression or relapse or death from any cause, up to 1557 days.)
- Relapse-free Survival (RFS)(From randomization until disease progression or relapse or death from any cause, up to 1557 days.)
研究者
研究点 (122)
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