Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed Primary Central Nervous System Large B-Cell Lymphoma Patients Intolerant to Haematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 2-year Progression-Free Survival
研究概览
简要总结
This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) [or temozolomide (TMZ), if intolerant to MTX] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.
详细描述
Participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either MTX or TMZ. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive zanubrutinib maintenance of 1 year (if tolerable).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years old;
- •Histopathologically confirmed CD20 positive primary large B-cell lymphoma of the central nervous system (CNS) or primary vitreoretinal lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours [primary large B-cell lymphoma of the CNS previously named as primary diffuse large B-cell lymphoma (DLBCL) of the CNS in the revised 4th edition];
- •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
ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
干预措施: Rituximab (Drug)
ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
干预措施: Methotrexate (Drug)
ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
干预措施: Zanubrutinib (Drug)
ZR-chemo
Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)
干预措施: Temozolomide (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
- Adverse Events(Baseline up to data cut-off (up to approximately 2 years))
- Complete Response (CR) Rate(Baseline up to data cut-off (up to approximately 2 years))
- Overall Response Rate (ORR)(Baseline up to data cut-off (up to approximately 2 years))
- Overall Survival (OS)(Baseline up to data cut-off (up to approximately 2 years))