An i3+3 Phase I Dose-per-Fraction Escalation Trial for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose Per Fraction of Radiation
研究概览
简要总结
This study focuses on using shortened courses of radiation for participants with relapsed/refractory Hodgkin/Non-Hodgkin lymphoma. Treatment radiation over 5-6 weeks is often standard of care for many people with lymphoma, but doctors leading this study aim to find out if using radiation for a shorter period of time can be safe for treating lymphoma and if so, what is the safest shortened dose of radiation for participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Maximum Tolerated Dose Per Fraction of Radiation
时间窗: 1 Month
Maximum tolerated dose of radiation per fraction among participants with relapsed/refractory Hodgkin/non-Hodgkin lymphoma as assessed by dose-limiting toxicities (severe side effects that limit the dose of radiation) defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- Overall Response Rate to Radiation Treatment(Up to 2 years after last dose of radiation)
- Local Control of Treated Lesions After Radiation Treatment(Up to 2 years after last dose of radiation)
- Rate of Reported Adverse Events Within 1 Month of Radiation(1 Month)
- Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation(Up to 2 years after last dose of radiation)
- Progression-Free Survival of Participants After Radiation Treatment(Up to 2 years after last dose of radiation)
- Overall Survival After Radiation Treatment(Up to 2 years after last dose of radiation)