jRCT2080223611已完成3 期
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects with Newly Diagnosed FLT3 ITD (+) Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi-center, double-blind, placebo-controlled
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm (at Screening)
- •Eastern Cooperative Oncology Group performance status 0-2 (at Screening)
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL), chronic myelogenous leukemia in blast crisis
- •Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy
结局指标
主要结局
Overall Survival
Overall survival, defined as the time from Randomization until death from any cause
次要结局
- Event Free Survival (EFS)
研究者
研究点 (1)
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