NCT06136351招募中2 期
A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- 2-year Progression-Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.
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
- •Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
- •FISH with del(17p)/TP53 mutation or ≥65 years; or<65 years but chemotherapy intolerance;
- •Life expectancy of > 3 months (in the opinion of the investigator);
- •Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m^2);
- •International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
- •Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
- •Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.
排除标准
- •Pregnant or lactating women;
- •Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA > detectable limit);
- •With acquired or congenital immunodeficiency;
- •With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF < 50%;
- •Known to be allergic to the test drug ingredients;
- •Diagnosed with or being treated for malignancy other than lymphoma;
- •With severe infection;
- •Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
- •Deemed unsuitable for the group.
研究组 & 干预措施
ZBR
Experimental
干预措施: Zanubrutinib (Drug)
ZBR
Experimental
干预措施: Rituximab (Drug)
ZBR
Experimental
干预措施: Bendamustin (Drug)
结局指标
主要结局
2-year Progression-Free Survival
时间窗: 2 years
Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.
次要结局
- CRR(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
- OS(Baseline up to data cut-off (up to approximately 2 years))
- Adverse Events(Baseline up to data cut-off (up to approximately 2 years))
- ORR(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular LymphomaAnn Arbor Stage II Follicular LymphomaGrade 1 Follicular LymphomaAnn Arbor Stage III Follicular LymphomaAnn Arbor Stage IV Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular LymphomaNCT06471738Chinese PLA General Hospital30
进行中（未招募）
1 期
Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell LymphomaDiffuse Large B-Cell LymphomaTransformed Follicular Lymphoma to Diffuse Large B-Cell LymphomaTransformed Marginal Zone Lymphoma to Diffuse Large B-Cell LymphomaNCT04850495Yazeed Sawalha38
Unknown
2 期
Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCLPrimary Mediastinal Large B Cell LymphomaEBV-Positive DLBCL, NosNCT04705129Ruijin Hospital40
招募中
1 期
Zanubrutinib and Tafasitamab in Mantle Cell LymphomaMantle Cell LymphomaNCT06029309Alvaro Alencar, MD27
已完成
1 期
Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell MalignanciesB-cell MalignanciesNCT04551963BeiGene26