NCT04622579Unknown2 期
Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≧80 years ;
- •ECOG score 0-2；
- •untreated with pathologically confirmed CD20+ DLBCL ;
- •expected life expectancy of ≥ 12 weeks;
- •capable of swallowing tablets;
- •GFR(by Cockcroft- Gault)≥30 ml/min;
- •can sign written informed consent to participate in the study.
排除标准
- •with CNS involvement;
- •with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;
- •with ≥ grade 2 peripheral neurophathy;
- •with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
- •received live vaccine within 28 days.;
- •HIV-positive;
- •thrombosis ;
- •GFR<30 mL/min;
- •other conditions not suitable for rituximab or lenalidomide application.
研究组 & 干预措施
lenalidomide combined with rituximab
Experimental
Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.
干预措施: lenalidomide combined with rituximab (Drug)
结局指标
主要结局
ORR
时间窗: 24 months
Overall response rate
次要结局
- CR(24 months)
- PFS(from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- OS(from date of treatment until the date of death from any cause, assessed up to 5 years)
研究者
Wenyu Li
professor of medicine
Guangdong Provincial People's Hospital
研究点 (1)
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