NCT03925935已完成1 期
A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 17
- 主要终点
- Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
研究概览
简要总结
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
结局指标
主要结局
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
时间窗: 24 hours
次要结局
- Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5(100 days)
- Overall survival(100 and 365 days post-ASCT)
- Time to lymphoid recovery(14, 28 and 100 days post-ASCT)
- Time to platelet engraftment(First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support)
- Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.(Day 0 to hospital discharge)
- Time to neutrophil engraftment(First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL)
- Progression-free survival(100 and 365 days post-ASCT)
- Non-relapse mortality(100 and 365 days post-ASCT)
研究者
研究点 (17)
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