JPRN-jRCT2071210133已完成2 期
A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Hiroki Kageyama0 个研究点目标入组 21 人开始时间: 2022年3月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
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) Hematocytologically or histopathologically proven ATL with positivity of anti-HTLV-1 antibody
- •2) Diagnosed as aggressive ATL (acute type, lymphoma type, or chronic type with unfavorable factor ATL)
- •3) Receiving at least one prior systemic therapy including mogamulizumab-containing regimen or, if mogamulizumab-intolerant or contraindication, one or more regimens of systemic therapies excluding mogamulizumab
- •4) Must have at least one measurable lesion, or evaluable lesion in either of peripheral blood or skin based on the response criteria defined in this study
- •5) ECOG PS of 0 to 1
- •6) Written informed consent
排除标准
- •1) Received prior allogeneic transplant, or prior autologous transplant within 12 weeks (84 days) prior to initiation of study treatment
- •2) Received prior treatment with PI3K inhibitors
- •3) Ongoing treatment for systemic bacterial, fungal, or viral infection
- •4) 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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