A Phase II Study of Bendamustine Plus Rituximab (BR) in Patients With Relapsed or Progressive Marginal Zone B-cell Lymphoma (MZBCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 22
- 主要终点
- Overall response rate based on Revised Response Criteria for Malignant Lymphoma
研究概览
简要总结
This study will be conducted to evaluate the efficacy of Bendamustine Plus Rituximab (BR) in patients with relapsed or progressive Marginal Zone B-cell Lymphoma (MZBCL).
详细描述
Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of bendamustine and rituximab in patients with MZBCL who has relapsed or progressive to prior chemotherapy or chemo-radiotherapy.
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
- •Histologically confirmed CD20-positive nodal or extranodal MZBCL
- •MZBCL patients who relapsed or progressed:
- •At least one and a maximum of four prior lines of chemotherapy
- •During or after the last chemotherapy or radiotherapy or
- •Without progression within 6 months of the last dose of rituximab-based regimen
- •Patients age ≥ 18 years
- •ECOG PS 0-2
- •At least one bidimensionally measurable disease
- •Adequate hematologic, renal, and hepatic functions
- •Women of child-bearing potential should use two appropriate methods of contraception during the study
- •Written informed consent
排除标准
- •Not all of the above inclusion criteria are met.
- •Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
- •Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of < 20mg/day for indications other than lymphomas
- •Evidence of CNS involvement by lymphomas
- •Active HBV/HCV infections, known HIV infection
- •Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer
- •Serious concurrent disease:
- •Patients who are pregnant or lactating
研究组 & 干预措施
Bendamustine plus rituximab(BR)
Intravenous bendamustine plus rituximab intravenously at 1st cycle and subcutaneously from 2nd cycle (to maximum 8th cycle).
干预措施: bendamustine plus rituximab (Drug)
结局指标
主要结局
Overall response rate based on Revised Response Criteria for Malignant Lymphoma
时间窗: 6 months
Overall Response Rate
时间窗: Up to disease progression, more than 30.12 months
Overall Response Rate (ORR) is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator. And ORR is based on Revised Response Criteria for Malignant Lymphoma
次要结局
- Safety based on NCI CTCAE version 4.0(1 year)
- Complete remission rate(6 months)
- Progression-free Survival(Up to disease progression, more than 30.12 months)
- The 3-year Survival Rate(From the 1st date of IP administration to the date of death)
研究者
Tae Min Kim
Professor
Seoul National University Hospital