NCT00199004已完成4 期
German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004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
- 60
- 试验地点
- 2
- 主要终点
- Remission rate (cytologic, Remission rate (molecular), 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 in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation
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
- 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
- •B-precursor ALL (common / pre B-ALL)
- •Standard risk
- •CD20 expression >20%
- •Ph/BCR-ABL negative
- •Age 15-65 years (55-65 if biologically younger)
- •Written informed consent
排除标准
- •Severe complications due to leukemia or secondary illnesses
- •Late relapse of childhood ALL
- •Cytostatic pretreatment
- •Pregnancy
- •Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- •Known severe allergy to foreign proteins
结局指标
主要结局
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
次要结局
- Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
研究者
研究点 (2)
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