A Phase II Study With Bendamustine Plus Brentuximab Vedotin in Hodgkin's Lymphoma and CD30+ Peripheral T-cell Lymphoma in First Salvage Setting: the BBV Regimen.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Overall objective response rate (ORR).
研究概览
简要总结
This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL.
A total of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated according to this treatment protocol.
详细描述
In the study, intravenous bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 and brentuximab will be given intravenously at a total dose of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6 cycles. All patients achieving a CR can be considered eligible to peripheral blood stem cell mobilization (to be performed with granulocytecolony stimulating factor alone) and may proceed to an ASCT at any time after cycle 4.
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 60 Years（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
研究组 & 干预措施
Bendamustine + Brentuximab for 6 cycles
Bendamustine 90 mg/m2 d1-2. Brentuximab vedotin 1.8 mg/kg d1.Every 21 days for 6 cycles.
干预措施: Brentuximab Vedotin (Drug)
Bendamustine + Brentuximab for 6 cycles
Bendamustine 90 mg/m2 d1-2. Brentuximab vedotin 1.8 mg/kg d1.Every 21 days for 6 cycles.
干预措施: Bendamustine (Drug)
结局指标
主要结局
Overall objective response rate (ORR).
时间窗: 1 year
Proportion of patients in CR or PR
次要结局
- Complete remission (CR) rate(1 year)
- Adverse Events(1 year)
- Duration of the response (DOR)(1 year)
- Progression-free survival (PFS)(1 year)
- Overall survival (OS)(1 year)