NCT04533581进行中（未招募）2 期
A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years or older at the submission of the written informed consent form
- •Patients that have undergone therapy after at least 2 prior systemic therapies (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL
- •Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to date
- •Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date
- •Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) "0 or 1"
排除标准
- •Patients with relapsed or refractory B-cell NHL who is categorized into Small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic lymphoma (LPL) by WHO classification
- •Patients who have been histologically confirmed FL Grade 3b transformation from Follicular lymphoma (FL) to an aggressive lymphoma at least once
- •Patients with lymphomatous involvement of the central nervous system
- •Patients with uncontrolled clinically significant illness
- •Patients with active interstitial lung disease or a history thereof
研究组 & 干预措施
ME-401
Experimental
干预措施: ME-401 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 2 years
ORR is measured as the proportion of subjects achieving the best response rating of complete response (CR) or partial response (PR) prior to first progressive disease (PD).
次要结局
- Efficacy of ME-401 as assessed by the duration of response (DOR)(Up to approximately 4 years)
- Efficacy of ME-401 as assessed by the progression-free survival (PFS)(Up to approximately 4 years)
- Efficacy of ME-401 as assessed by the objective response rate (ORR)(Up to approximately 4 years)
- Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)(Up to approximately 4 years)
- Plasma concentration level of ME-401(Up to approximately 4 years)
- Efficacy of ME-401 as assessed by CR(Up to approximately 4 years)
- Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)(Up to approximately 4 years)
- Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)(Up to approximately 4 years)
研究者
研究点 (30)
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