A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
研究概览
简要总结
:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.
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 75 Years（Adult, 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
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Prednisone (Drug)
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Zanubrutinib (Drug)
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Obinutuzumab (Drug)
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Cyclophosphamide (Drug)
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Vincristine (Drug)
Treatment arm
Induction: Zanubrutinib and G-CHOP 4-6cycles
Maintenance: Zanubrutinib and Obinutuzumab 1 year
干预措施: Doxorubicin (Drug)
结局指标
主要结局
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
时间窗: From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
次要结局
- Objective Response rate after induction by investigator (INV)(From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days))
- Progression free survival (PFS)(From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years)
- Overall survival (OS)(From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years)