NCT02110394已完成不适用
Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 34
- 主要终点
- Overall response rate
研究概览
简要总结
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia
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
- •Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin
- •Informed Consent Form for personal data handling signed by the program participant
排除标准
- •Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL
- •Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
- •Contraindications for Ribomustin usage in accordance with product label
结局指标
主要结局
Overall response rate
时间窗: Within 60-90 days after end of treatment
次要结局
- Time to Progression (TTP)(60 months)
- Adverse drug reactions(At all post-treatment visits (up to 30 days after end of treatment))
- Treatment Failure (TF)(Within 60-90 days after end of treatment)
- Progression-Free Survival (PFS)(60 months)
- Relapse following complete or partial remission(60 months)
- Overall survival(60 months)
- Quality of Life of patients receiving Ribomustin therapy(At all post-treatment visits (up to 30 days after end of treatment))
研究者
研究点 (34)
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