EUCTR2006-006852-37-DE进行中（未招募）1 期
A phase III randomized, double-blind study of induction(daunorubicin/cytarabine)and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML) - PKC412A2301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 714
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
- •- Unequivocal diagnosis of AML (> 20% blasts in the bone marrow based on the
- •WHO classification, excluding M3 (acute promyelocytic leukemia9
- •- Documented FLT3 mutation
- •- Age = 18 and < 60 years
- •-- No prior chemotherapy for leukemia or myelodysplasia with few
- •exception listed (see protocol section 4)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 714
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients who have developed therapy related AML after prior RT or chemotherapy
- •for another disorder or cancer
- •- Patients with symptomatic congestive heart failure
- •- Total Bilirubin < 2.5 upper limit of normal
- •- Pregnant or nursing patients
研究者
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