NCT02020161Unknown4 期
Clinical Guidelines for APL Treatment
PETHEMA Foundation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence within 1 year of treatment
研究概览
简要总结
Therapeutic guidelines for treatment of patients with de novo APL to be used by every institution that wants to follow them. All patients who are reported may be retrospectively analyzed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genetic diagnosis of acute promyelocytic leukemia
排除标准
- •No exclusion criteria
研究组 & 干预措施
ATRA-Idarubicin
Experimental
干预措施: Atra (Drug)
ATRA-Idarubicin
Experimental
干预措施: Idarubicin (Drug)
ATRA-Idarubicin
Experimental
干预措施: methotrexate (Drug)
结局指标
主要结局
Recurrence within 1 year of treatment
时间窗: 3 years
Induction therapy with simultaneous ATRA (45 mg/m2 day until CR) and idarubicin (12 mg/m2 day on days 2, 4, 6 and 8 or 12 mg/m2 day on days 2, 4 and 6 in patients older than or equal to 60 years). Three monthly consolidation courses with ATRA Maintenance therapy with ATRA (45 mg/m2/d, days 1-15 every 3 months), and low dose chemotherapy with methotrexate (15 mg/m2/d, weekly) and 6-mercaptopurine (50 mg/m2/d) for two years.
次要结局
未报告次要终点
研究者
研究点 (1)
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