Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria
研究概览
简要总结
The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.
详细描述
BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate.
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice.
Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Confirmed diagnosis of chronic lymphocytic leukemia
- •Patients treated with first-line BR for active disease requiring treatment
- •Cumulative Illness Rating Scale (CIRS) > 6
- •Informed consent to data collection
排除标准
- •Patients treated with BR within prospective clinical trials
研究组 & 干预措施
BR in CLL
Patients receive bendamustine hydrochloride 90mg/m2 IV on days 1 and 2 each cycle. Patients also receive rituximab 375 mg/m2 IV on day 1 at first cycle and 500 mg/m2 on day 1 all subsequent cycles.
干预措施: Bendamustine and Rituximab (Drug)
结局指标
主要结局
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria
时间窗: 8 months
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.)
Overall response rate
时间窗: 8 months
Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response.
次要结局
- Progression-free survival(3 years)
- Overall survival(3 years)