jRCT2071210133已完成不适用
A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 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
- •Hematocytologically or histopathologically proven ATL with positivity of anti-HTLV-1 antibody
- •Diagnosed as aggressive ATL (acute type, lymphoma type, or chronic type with unfavorable factor ATL)
- •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
- •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
- •ECOG PS of 0 to 1
- •Written informed consent
排除标准
- •Received prior allogeneic transplant, or prior autologous transplant within 12 weeks (84 days) prior to initiation of study treatment
- •Received prior treatment with PI3K inhibitors
- •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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