NCT01118234已完成3 期
International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
Arbeitsgemeinschaft medikamentoese Tumortherapie22 个研究点 分布在 3 个国家目标入组 256 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 22
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •ECOG performance status 0-2
- •Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
- •Patient must be in complete remission or partial remission after an induction treatment containing rituximab
- •ANC (absolute neutrophil count) > 1,0 x 10e9 /L
- •Life expectancy > 6 months
- •Patient´s written informed consent
- •Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter
排除标准
- •Active uncontrolled bacterial, viral or fungal infection
- •Significantly reduced organ functions and bone marrow dysfunction not due to CLL
- •creatinine clearance of below 30mL/min
- •Patients with a history of other malignancies within 2 years prior to study entry
- •Patients with a history of severe cardiac disease
- •Other known comorbidity with the potential to dominate survival
- •Transformation to aggressive B-cell malignancy
- •Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
- •Medical condition requiring prolonged (> 1 month) use of oral corticosteroids
- •Pregnant or breast feeding women
- •Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
研究组 & 干预措施
Rituximab
Experimental
Treatment with Rituximab 375 mg/m² every 3 months for 24 months
干预措施: Rituximab (Drug)
结局指标
主要结局
progression free survival
时间窗: 48 months
Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.
次要结局
- MRD (minimal residual disease) progression free survival(48 months)
- conversion rate to MRD negative(48 months)
- median MRD levels(48 months)
- time to next treatment(48 months)
- conversation rate to CR(48 months)
- Safety of Rituximab maintenance treatment in patients with CLL(48 months)
- benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression(48 months)
- effect of MRD levels on clinical PFS and OS(48 months)
- event free survival(48 months)
- overall survival(48 months)
研究者
研究点 (22)
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