EUCTR2005-002258-23-IT进行中（未招募）不适用
A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
CEPHALON EUROPE0 个研究点目标入组 220 人开始时间: 2005年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Cytological confirmation of AML ?Relapsed disease following first CR of duration 1 - 24 months Time from first relapse to study entry £ 30 days ?Confirmation of FLT 3 positive status after point of initial relapse ?Aged ³ 18 years and older ?Written informed consent ?Ability to understand and comply with study restrictions ?No co-morbid conditions that would limit life expectancy to <3 months ?ECOG 0 - 2 ?Pregnancy precautions as appropriate
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Bilirubin >2 times ULN, ALT or AST >3 times ULN ?Serum creatinine >1.5 mg/dL ?Resting ejection fraction <45% (MEC patients only) ?Untreated or progressive infection ?Physical or psychiatric condition that may compromise participation ?Known central nervous system involvement with AML ?Any prior treatment with a FLT 3 inhibitor ?Requirement for HIV protease inhibitors ?Active gastrointestinal ulceration or bleeding ?Use an investigational drug that is not expected to be cleared by the start of CEP-701
研究者
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