JPRN-jRCT2031210529已完成2 期
A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Follicular Lymphoma
Suzuki Kenta0 个研究点目标入组 36 人开始时间: 2021年12月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1) Histologically diagnosed as Grade 1, 2 or 3a FL according to WHO classification
- •2) Relapsed or refractory disease after receiving at least two prior systemic therapies
- •3) At least one measurable lesion according to the Lugano classification
- •4) ECOG PS of 0 to 1
- •5) Written informed consent
排除标准
- •1) Clinically or histologically suspected to be transformation from FL to an aggressive lymphoma or diagnosed as Grade 3b FL according to WHO classification
- •2) History of interstitial pneumonia or severe lung dysfunction
- •3) 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.)
- •4) Ongoing treatment for systemic bacterial, fungal, or viral infection
- •5) Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 14 days of enrollment
研究者
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