NCT01034410终止2 期
An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia
Antisoma Research14 个研究点 分布在 4 个国家目标入组 90 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
研究概览
简要总结
This is an open label randomized controlled phase II study of AS1411 combined with Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML as defined by the World Health Organization (WHO) classification (Vardiman 2009)
- •Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy with curative intent) or AML in first relapse
- •ECOG Performance status 0, 1 or 2
- •Age > 18 and < 70 years
- •For patients presenting with primary refractory AML, > 20% blasts on baseline bone marrow assessment
- •For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow assessment
排除标准
- •An initial diagnosis of acute promyelocytic leukemia (as defined by French-American-British criteria (Bennett 1976))
- •Secondary AML, defined as AML evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
- •Clinically active CNS leukemia
- •Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
- •Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
研究组 & 干预措施
Control
Active Comparator
cytarabine 2g/m2 bid Days 4-7
干预措施: Cytarabine (Drug)
AS1411-40
Experimental
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
干预措施: AS1411 (Drug)
AS1411-40
Experimental
AS1411 40mg/kg/day d1-7 plus cytarabine 2g/m2 bid days 4-7
干预措施: Cytarabine (Drug)
AS1411-80
Experimental
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
干预措施: AS1411 (Drug)
AS1411-80
Experimental
AS1411 80mg/kg/day d1-7, cytarabine 2g/m2 bid days 4- 7/ bid d4-7
干预措施: Cytarabine (Drug)
结局指标
主要结局
To compare the response rate (CR + CRi) of AS1411 at 40 and 80mg/kg/day in combination with cytarabine therapy with the response rate (CR + CRi) of cytarabine therapy alone
时间窗: Dec 2011
次要结局
- To compare duration of remission, disease free survival and overall survival of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.(Dec 2011)
- To compare the time to hematological recovery of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.(Dec 2011)
- To compare the safety of AS1411 at 40 or 80mg/kg/day in combination with cytarabine therapy with that of cytarabine alone.(Dec 2011)
- To evaluate and compare a range of PD markers in patients administered AS1411 in combination with cytarabine therapy with the same PD markers in patients administered cytarabine therapy alone.(Dec 2011)
- To further define the PK of AS1411(Dec 2011)
研究者
研究点 (14)
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