jRCT2031230525进行中（未招募）不适用
EPKINLY Subcutaneous Injection General use-results surveillance (All case) of relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma: OBSC3013-39D-E
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Genmab K.K.
- 入组人数
- 250
- 主要终点
- cytokine release syndrome (CRS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •All patients treated with EPKINLY
排除标准
- 未提供
结局指标
主要结局
cytokine release syndrome (CRS)
The incidence of cytokine release syndrome (CRS)
immune effector cell-associated neurotoxicity syndrome (ICANS)
The incidence of immune effector cell-associated neurotoxicity syndrome (ICANS)
infections
The incidence of infections
cytopenia
The incidence of cytopenia
tumor lysis syndrome
The incidence of tumor lysis syndrome
progressive multifocal leukoencephalopathy
The incidence of progressive multifocal leukoencephalopathy
次要结局
- The timing of CRS onset
- The rate of CRS preventive measures
- The compliance with CRS and ICANS management guidance
- The incidence of all adverse events and adverse drug reactions that occurred in clinical use
- Overall response rate as determined by Lugano Response Criteria for Malignant Lymphoma (2014)
研究者
相似试验
招募中
Unknown
EPKINLY Subcutaneous Injection General use-results surveillance (All case): OBSC3013-39D-ERelapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphomaJPRN-jRCT2031230525Genmab K.K. Drug safety and pharmacovigilance250
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