Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Event free survival
研究概览
简要总结
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma
详细描述
A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 0 years to 17 years 11 months
- •Established on the basis of histological and immunohistochemical studies, the diagnosis of PMLBL (the presence of programmed death-ligand on tumor cells is not necessary)
- •Lack of specific therapy for lymphoma
- •Signed informed consent
排除标准
- •History of specific therapy for lymphomas.
- •Drug intolerance
研究组 & 干预措施
The only ARM consists of nivolumab combined with DA-EPOCH-R protocol
Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2
干预措施: Nivolumab (Drug)
结局指标
主要结局
Event free survival
时间窗: 5 year
Kaplan-Meyer estimate
次要结局
- Overall survival(5 year)
- Progression free survival(5 year)
研究者
Ivan S Moiseev
Vice-director of RM Gorbacheva Research Institute
St. Petersburg State Pavlov Medical University