Dexamethasone, Cytarabine, Cisplatin and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP-cHL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
研究概览
简要总结
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
详细描述
A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Histologically confirmed Hodgkin's lymphoma
- •Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min > 15 mm in the longest diameter or > 10 mm in the short axis)
- •World Health Organization (WHO) performance status < 2
- •Relapsed or refractory to at least one prior treatment line
- •No prior therapy with DHAP or Nivolumab
- •No severe concurrent illness
排除标准
- •History of HIV
- •Active Hepatitis B or Hepatitis C infection
- •Uncontrolled infection (requiring intravenous treatment) at the time of enrollment
- •Pregnancy or breastfeeding
- •Somatic or psychiatric disorder making the patient unable to sign informed consent
- •Active or prior documented autoimmune disease requiring systemic treatment
- •No receiving a live vaccine within 30 days prior to first dose of nivolumab
- •History of non-infectious pneumonitis that required steroids
- •Other malignancy
研究组 & 干预措施
Patients with relapsed/refractory Hodgkin's lymphoma
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
干预措施: Nivolumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
时间窗: up to 6 months
Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano classification and duration of response
次要结局
- Progression-Free Survival(up to 12 months)
- Overall Survival(up to 12 months)
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03(up to 6 months)