Observational Study of Low Dose FCR in the Treatment of Elderly/Comorbid Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: The Q-lite Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Toxicity
研究概览
简要总结
FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold standard in treatment of younger and physically fit CLL patients. These excellent results, however, cannot be generally applied to the whole CLL population. This is because the median age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear whether elderly/comorbid patients could profit from newer treatment approaches such as purine analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.
详细描述
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of low dose FCR for CLL patients treated in clinical practice.
Specific data of interest are: comorbid concitions, concomitant medication, CLL characteristics, prior treatment regimens, adverse events, reasons for discontinuation low dose FCR, overal response rates, complete response rate, progression-free survival, overall survival.
This is an observational, non-interventional, medical record review study in CLL patients. A total of 200 patients with CLL who have been previously treated with low dose FCR will be eligible for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 CLL or SLL
- •previously treated by low dose FCR for active disease requiring treatment per IWCLL criteria
- •dose reduction of fludarabine and cyclophosphamide due to age, comorbid conditions, or reduce creatinine clearance
排除标准
- •patients treated with low dose FCR within prospective clinical trials
研究组 & 干预措施
Low dose FCR in Elderly/Comorbid CLL
low dose FCR
干预措施: low-dose FCR (Drug)
结局指标
主要结局
Toxicity
时间窗: 8 months
Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)
次要结局
- Progression-free survival(3 years)
- Complete response rate(8 months)
- Quality of life(3 years)
- Overall response rate(8 months)
- Overall survival(3 years)