A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.
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
- •Histopathological diagnosis of classical Hodgkin lymphoma
- •Failed standard front-line therapy
- •Measurable disease of at least 1.5 cm as documented by radiographic technique
- •Eastern Cooperative Oncology Group performance status less than or equal to 2
排除标准
- •Received prior salvage therapy, including radiotherapy
- •Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
- •Concurrent use of other investigational agents
研究组 & 干预措施
Brentuximab Vedotin + Bendamustine
Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
干预措施: brentuximab vedotin (Drug)
Brentuximab Vedotin + Bendamustine
Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
干预措施: bendamustine (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 13.8 months
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.
Complete Remission Rate
时间窗: Up to 4.6 months
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
次要结局
- Overall Best Response Rate(Up to 4.6 months)
- Duration of Response(Up to 47.8 months)
- Incidence of Dose-limiting Toxicities(Up to 3 weeks; first cycle of therapy through the first day of Cycle 2)
- Progression-free Survival(Up to 49 months)