jRCT2031210529已完成不适用
A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Follicular Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically diagnosed as Grade 1, 2 or 3a FL according to WHO classification
- •Relapsed or refractory disease after receiving at least two prior systemic therapies
- •At least one measurable lesion according to the Lugano classification
- •ECOG PS of 0 to 1
- •Written informed consent
排除标准
- •Clinically or histologically suspected to be transformation from FL to an aggressive lymphoma or diagnosed as Grade 3b FL according to WHO classification
- •History of interstitial pneumonia or severe lung dysfunction
- •Received prior treatment with duvelisib (Patients who were refractory to PI3K inhibitors other than duvelisib or who experienced severe adverse events during treatment with the PI3K inhibitor were also excluded.)
- •Ongoing treatment for systemic bacterial, fungal, or viral infection
- •Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 14 days of enrollment
结局指标
主要结局
-
Overall response rate
次要结局
未报告次要终点
研究者
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