jRCT2011210063进行中（未招募）不适用
A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care versus Best Supportive Care as Maintenance Therapy in Japanese Subjects with Acute Myeloid Leukemia in Complete Remission
Bristol-Myers Squibb0 个研究点目标入组 66 人开始时间: 2022年1月17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
- 66
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 55age old over 至 No limit（—）
- 性别
- All
入选标准
- •To evaluate the efficacy of CC-486 as maintenance therapy by using RFS in Japanese participants with more than 55 years with AML, who have achieved first CR or CRi after induction with intensive chemotherapy
- •with or without consolidation chemotherapy.
排除标准
- •To determine the effect of CC-486 as maintenance therapy on OS, time to relapse from CR/CRi, and time to discontinuation from treatment
- •To determine safety and tolerability
- •To determine PK
- •To determine the effect of CC-486 on HRQoL
结局指标
主要结局
-
RFS
次要结局
- Safety/tolerability
- Participant-reported outcomes
研究者
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