Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
详细描述
Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of rituximab plus MG4101 in patients with indolent CD20-positive NHLs who has relapsed or refractory 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)
- •CD20-positive iNHL patients who relapsed or progressed
- •ECOG PS 0-2
- •At least one bidimensionally measurable disease (or presence of IgM paraproteinemia ≥ 2 x ULN for Waldenstrom macroglobulinemia)
- •Adequate hematologic, renal, and hepatic functions
- •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 > 10mg/day during last 28 days
- •Evidence of CNS involvement by lymphomas
- •Active HBV/HCV infections, known HIV infection
- •Prior diagnosis of cancers within 5 years
- •Serious concurrent cardiovascular disease
- •Patients who are pregnant or lactating
研究组 & 干预措施
Rituximab + MG4101
Drug: Rituximab + MG4101
Induction phase:
Rituximab (Truxima) 375mg/m2 IV Weekly (X4) MG4101 3x107 cells/kg IV Weekly (X4) Maintenance phase
Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) MG4101 3x107 cells/kg IV q 4 weeks (X4)
干预措施: Rituximab + MG4101 (Drug)
结局指标
主要结局
Overall response rate
时间窗: Through treatment completion, an average of 25 weeks
Investigator-assessed, confirmed objective response by revised response criteria
次要结局
- Complete remission rate(Through treatment completion, an average of 25 weeks)
- Progression-free survival(From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years)
- Overall survival(Through study completion, an average of 2 years)
研究者
Tae Min Kim
Professor
Seoul National University Hospital