NCT06549335尚未招募2 期
The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas
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
- •Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- •Treatment naive
- •Age ≥ 18 years
- •Indications for treatment confirmed
- •Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
- •Must has measurable lesion in CT or PET-CT prior to treatment
- •Considered suitable for ZGR regimens
- •Informed consented
排除标准
- •Transformed follicular lymphoma or 3B follicular lymphoma;
- •HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- •Any drug contraindication in the treatment plan
- •Pregnant or lactating women
- •Patients judged by other researchers to be unsuitable for inclusion in the study
研究组 & 干预措施
Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Experimental
干预措施: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At the end of Cycle 6 (each cycle is 28 days)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
次要结局
- Complete response rate (CR)(At the end of Cycle 6 (each cycle is 28 days))
- Partial response rate (PR)(At the end of Cycle 6 (each cycle is 28 days))
- 2-year progression free survival rate(Baseline up to data cut-off (up to approximately 2 years))
- Duration of response(Baseline up to data cut-off (up to approximately 2 years))
- 2-year overall survival rate(Baseline up to data cut-off (up to approximately 2 years))
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital
研究点 (1)
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