NCT06669143尚未招募2 期
The Efficacy and Safety of Zanubutinib-based for Post-remission Maintenance in Patients With Diffuse Large B-cell Lymphoma Who Are Intolerant to Intense First-line Chemotherapy
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
- 19
- 主要终点
- 2-year recurrence-free survival
研究概览
简要总结
This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were informed about this study and voluntarily signed written informed consent
- •Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
- •DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
- •Life expectancy > 3 months
- •Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
- •Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
排除标准
- •Contraindication to any drug in the study
- •Seropositive for or active viral infection with HBV or HCV
- •Human immunodeficiency virus (HIV) infection
- •Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
- •QTc (corrected by Fridericia formula): >480ms;
- •Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
- •If female, the patient is pregnant or breast-feeding
- •Any uncontrolled active systemic infection
研究组 & 干预措施
Zanubrutinib and Lenalidomide
Experimental
干预措施: Zanubrutinib (Drug)
Zanubrutinib and Lenalidomide
Experimental
干预措施: Lenalidomide (Drug)
结局指标
主要结局
2-year recurrence-free survival
时间窗: 2 years after enrollment
次要结局
- Overall survival(From enrollment to study completion, a maximum of 4.5 years)
- Overall response rate(up to 2 year, at the end of maintenance)
- Complete response rate(up to 2 year, at the end of maintenance)
研究者
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