NCT02080884已完成不适用
A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
研究概览
简要总结
This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
- •aged >/= 18 years
排除标准
- •Pregnant or breast-feeding
- •Receipt of an investigational drug within 30 days prior to entering the study
结局指标
主要结局
Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
时间窗: 7 months
次要结局
- ORR analysed according to concomitant chemotherapy(7 months)
- ORR analysed according to age(7 months)
- ORR analysed according to CIRS score(7 months)
- ORR analysed according to certain chromosomal abnormalities(7 months)
研究者
研究点 (15)
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