A Phase II, Open-Label, Multicenter Study to Assess the Safety and Anti-Tumor Efficacy of AZD4205 in Participants With Peripheral T Cell Lymphoma Who Have Responded After First-Line Standard Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 23
- 主要终点
- Adverse events and serious adverse events (graded by CTCAE version 5.0)
研究概览
简要总结
This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg once daily in participants with PTCL who have achieved tumor response after first-line systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT assessed by the investigator as ineligible for HSCT or have no plan for HSCT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AZD4205 treatment
Cohort 1: Participants achieving a CR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.
Cohort 2: Participants achieving a PR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.
干预措施: AZD4205 (Drug)
结局指标
主要结局
Adverse events and serious adverse events (graded by CTCAE version 5.0)
时间窗: up to 2 years
To assess the safety and tolerability of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy
次要结局
- Cohort 1: Disease Free Survival (DFS)(up to 2 years)
- Cohort 2: Progression-free Survival (PFS)(up to 2 years)
- Cohort 2: Progression-free Survival (PFS) rate at 1 year from the first dose of investigational product(1 year)
- Cohort 2: Objective Response Rate (ORR)(up to 2 years)
- Cohort 2: Duration of Response (DoR)(up to 2 years)
- Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product(1 year)