Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma
详细描述
Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.
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
- •Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
- •No past history of autoimmune disease
- •Age > 18 years
- •Ejection fraction > 50%
排除标准
- •Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
- •Uncontrolled infection
- •Inability to sign informed consent
研究组 & 干预措施
Nivo40-AVD
Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15
干预措施: Nivolumab (Drug)
Nivo40-AVD
Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15
干预措施: Doxorubicin (Drug)
Nivo40-AVD
Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15
干预措施: Vinblastine (Drug)
Nivo40-AVD
Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Complete remission and complete metabolic response(2 years)
- Adverse events(2 years)