NCT00199069已完成4 期
Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
Goethe University1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 1993年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- remission rate, disease free survival, overall survival
研究概览
简要总结
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Lymphocytic Leukemia
- •Age 15 - 65 years
排除标准
- •Serious secondary diseases which may compromise intensified chemotherapeutical treatment
- •Serious psychiatric diseases, which may compromise compliance with therapy
- •HIV-1 or HIV-2 Infection
- •Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
- •Patients without central diagnosis who cannot be allocated to a risk group
结局指标
主要结局
remission rate, disease free survival, overall survival
次要结局
- death in induction, toxicity, time and dose compliance
研究者
Nicola Goekbuget
Study Coordinator
Goethe University
研究点 (1)
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