NCT00199056已完成4 期
Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)
Goethe University2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 1999年10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
- 225
- 试验地点
- 2
- 主要终点
- Remission rate,Remission duration,Disease free survival,Overall survival
研究概览
简要总结
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 lymphoblastic leukemia (pro-B, common, pre-B, early T, T)
- •Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
排除标准
- •Severe comorbidity
- •Cytostatic pre-treatment
- •Pregnancy
- •Missing written informed consent
结局指标
主要结局
Remission rate,Remission duration,Disease free survival,Overall survival
次要结局
- Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD
研究者
Nicola Goekbuget
Head of GMALL
Goethe University
研究点 (2)
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