The Efficacy and Safety of Zanubrutinib, Rituximab and Lenalidomide (ZR2) Versus Rituximab Combined With Low-dose CHOP (R-miniCHOP) in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years: A Multicenter, Prospective, Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of zanubrutinib, rituximab and lenalidomide (ZR2) versus rituximab combined with low-dose CHOP (R-miniCHOP) in the treatment of unfit or frail de novo diffuse large B-cell lymphoma patients aged older than or equal to 70 years
详细描述
This study will evaluate the efficacy and safety of ZR2 versus R-miniCHOP in the treatment of unfit or frail de novo diffuse large B-cell lymphoma patients aged older than or equal to 70 years. Subjects will be randomly assigned 1:1 to ZR2 or R-miniCHOP regimen. The stratification will be performed according to international prognostic index (0-2 / 3-5).
Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day 1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously, every 21 days. Patients in R-miniCHOP group will receive rituximab 375 mg/m² on day 1, cyclophosphamide 400 mg/m², doxorubicin 25 mg/m², and vincristine 1 mg on day 2, and prednisone 40 mg/m² on days 2-6, every 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older 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
ZR2
six courses of zanubrutinib, rituximab and lenalidomide
干预措施: six courses of zanubrutinib, rituximab and lenalidomide (Drug)
R-miniCHOP
six courses of rituximab combined with low-dose CHOP
干预措施: six courses of rituximab combined with low-dose CHOP (Drug)
结局指标
主要结局
Progression free survival
时间窗: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
次要结局
- Overall survival(Baseline up to data cut-off (up to approximately 2 years))
- Complete response rate(At the end of Cycle 6 (each cycle is 21 days))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(From enrollment to study completion, a maximum of 4 years)
- Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-ELD14 (Elderly Module)(Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion)
- Percentage of Participants Achieving Meaningful Improvement in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)(Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion)
- Percentage of Participants Achieving Meaningful Improvement in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)(Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion)
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital