NCT00962767已完成3 期
A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 168 人开始时间: 2002年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.
研究概览
简要总结
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
a
Experimental
2 doses of gemtuzumab ozogamicn administered at monthly intervals
干预措施: gemtuzumab ozogamicin (Drug)
b
Active Comparator
2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX)
干预措施: ATRA plus 6-MP and MTX (Drug)
结局指标
主要结局
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.
时间窗: 5 years
次要结局
- Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.(5 years)
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