NCT04460248进行中（未招募）2 期
The Efficacy and Safety of Zanubrutinib, Lenalidomide and Rituximab (ZR2) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) regimen in elderly treatment-naive patient with diffuse large B-cell 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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL)
- •Refuse to undergo systemic chemotherapy or not suitable for chemotherapy
- •Radiography detects measurable lesions defined as at least 1 clearly defined lesion/nodule with both long and short diameters longer than or equal to 1.5cm
- •Life expectancy of at least 3 months determined by researchers
- •The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
- •Research drugs have not been used before
排除标准
- •The patient has received systemic or local anti-tumor treatment, including chemotherapy, within three weeks before enrollment
- •The patient has complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- •Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- •Neutrophils<1.5 x 10^9/L
- •Platelets<80 x 10^9/L
- •ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit
- •Creatinine is 1.5 times higher than the normal upper limit
- •Other concurrent and uncontrolled medical conditions that the researchers believe that they will affect the patient's participation in the study, including patients with psychosis or other known or suspected patients who cannot fully comply with the research protocol
- •HIV-infected patients
- •Patients with HbsAg positive are required to have negative HBV DNA before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and if the result is positive, anti-viral treatment is also required, and negative HBV DNA is required before entering the group
- •Other medical conditions determined by the researchers that may affect the study
研究组 & 干预措施
Zanubrutinib, Lenalidomide and Rituximab (ZR2)
Experimental
干预措施: Zanubrutinib, Lenalidomide and Rituximab (ZR2) (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
次要结局
- 2-year progression-free survival(2 years after enrollment)
- 2-year overall survival(2 years after enrollment)
- Incidence rate of adverse events(From enrollment to study completion, a maximum of 3 years.)
研究者
Zhao Weili
First Deputy Director of Shanghai Institute of Hematology
Ruijin Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)Follicular LymphomaNCT06549335Ruijin Hospital66
尚未招募
2 期
Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial RemissionDiffuse Large B Cell LymphomaNCT06669143Ruijin Hospital19
已完成
1 期
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver FunctionHepatic Insufficiency & Healthy SubjectsNCT03465059BeiGene29
招募中
2 期
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell LymphomaRefractory or Relapsed Diffuse Large B Cell LymphomaNCT06554600Second Affiliated Hospital, School of Medicine, Zhejiang University36
招募中
3 期
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 YearsDiffuse Large B-Cell LymphomaNCT05179733Ruijin Hospital280