Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 681
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
研究概览
简要总结
This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.
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
- •CLL requiring treatment
- •Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
- •After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)
排除标准
- •Participants with contraindication to rituximab treatment
研究组 & 干预措施
Participants With CLL
Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
时间窗: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.
Percentage of Participants Without Progression or Death
时间窗: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.
次要结局
- Percentage of Participants With B-Symptoms(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With General Symptoms(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Progression and Death(From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months))
- Percentage of Participants Who Received Each Treatment During the Course of Study(Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month))
- Mean Body Weight(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Karnofsky Performance Status Index(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Best Overall Response (BOR)(From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months))