NCT05887726尚未招募2 期
A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
Liaoning Tumor Hospital & Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月1日最近更新:
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
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete response rate（CRR）
研究概览
简要总结
This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.
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
- •Histologically confirmed DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky)；
- •Age ≥ 18 years old;
- •At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm);
- •ECOG performance status 0-2;
- •Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range；
- •Hematopoietic function should meet the following conditions: Platelet count ≥50×109/L; Hemoglobin ≥ 8.0g /dL; Absolute count of neutrophil (ANC)≥1.0×109/L;
- •Expected survival of ≧3 months
排除标准
- •Major surgery within 4 weeks before treatment;
- •Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases);
- •Patients who cannot cooperate with treatment or follow-up on time.
- •Pregnant or lactating females;
- •any uncontrolled active systemic infection requiring intravenous (IV) antibiotics;
- •There was a history of other active malignant diseases within the 2 years prior to study entry, except for: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) previous malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
- •History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or spontaneous bleeding requiring blood transfusion or other medical intervention
- •Human immunodeficiency virus (HIV) infection or the following serological status reflecting the presence of active hepatitis B or C virus infection: a. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) are present. Patients who are HBCAB-positive, HBsAg negative, have no hepatitis b virus (HBV) DNA (< 20 IU/mL), and agree to be monitored for HBV virus reactivation can be enrolled. Antibodies to the hepatitis C virus (HCV) are present. HCV antibody-positive patients with no HCV RNA detected could be included in the group.
- •The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or pose a risk to the study.
- •The researchers think it is not suitable to participate in this experiment.
研究组 & 干预措施
Zanubrutinib + R-CHOP
Experimental
干预措施: Zanubrutinib (Drug)
Zanubrutinib + R-CHOP
Experimental
干预措施: Rituximab (Drug)
Zanubrutinib + R-CHOP
Experimental
干预措施: Cyclophosphamide (Drug)
Zanubrutinib + R-CHOP
Experimental
干预措施: Epirubicin (Drug)
Zanubrutinib + R-CHOP
Experimental
干预措施: Vincristine (Drug)
Zanubrutinib + R-CHOP
Experimental
干预措施: Prednisone (Drug)
结局指标
主要结局
Complete response rate（CRR）
时间窗: Up to approximately 2.5 years
次要结局
- Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.(At 2 years)
- Overall survival (OS)(Up to approximately 2.5 years)
- Overall response rate （ORR）(Up to approximately 2.5 years)
- Progression-free Survival(PFS)(Up to approximately 2.5 years)
- Duration of Response(At 2 years)
- Incidence of adverse event(At 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal CancerLocally Advanced Rectal CancerNCT06760520The First Affiliated Hospital of Zhengzhou University40
尚未招募
2 期
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive CarcinomaPD-1 AntibodyDC-CellNK-CellGastrointestinal TumoursNCT05461235China Medical University, China1
Unknown
2 期
Clinical Study on the First-line Treatment of Advanced Biliary System Tumors With Tripley Monoclonal Antibody Combined With GEMOX RegimenAdvanced Biliary Tract TumorsNCT04191343Zhejiang Cancer Hospital20
招募中
2 期
Combination of TURP and Standard Systemic Therapy for MPCaMetastatic Prostate CancerNCT06655259Fudan University200
终止
2 期
Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy PatientsActive Moderate to Severe Graves' OrbitopathyNCT05394857Suzhou Suncadia Biopharmaceuticals Co., Ltd.7