Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- change from baseline infusion-related reactions at cycle 6
研究概览
简要总结
This study aimed to analyze the safety of 90-min intravenous rapid infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma and to provide evidence for the applicability of rapid infusion regimens in chemotherapy in China.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of B-cell lymphoma and with indications for obinutuzumab treatment
- •No significant organ damage
- •ECOG score of 0-2;
- •Life expectancy ≥ 6 months
- •Informed consent
排除标准
- •Pregnant or lactating
- •Serologically tested positive for human immunodeficiency virus or hepatitis B virus infection but had not received treatment
- •Severe hepatic or renal insufficiency
- •Severe cardiovascular disease.
研究组 & 干预措施
Intravenous rapid infusion of obinutuzumab
Patients with B-cell non-Hodgkin's lymphoma were treated with the standard infusion regimen of obinutuzumab in cycle 1, and for patients who did not develop severe infusion-related reactions in cycle 1, a rapid 90-min obinutuzumab infusion regimen was used from cycle 2 onward while recording any occurrence of infusion reactions in different treatment cycles.
干预措施: intravenous rapid infusion of obinutuzumab (Drug)
结局指标
主要结局
change from baseline infusion-related reactions at cycle 6
时间窗: at the end of cycle 6(each cycle is 21~28 days)
The severity of an IRR was graded according to the Common Terminology Criteria for Adverse Events ver 5.0 published by the National Cancer Institute
次要结局
未报告次要终点