Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free Survival（PFS）
研究概览
简要总结
Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.
详细描述
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.
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 Non-GCB DLBCL with extrinsic involvement；
- •Measurable disease of at least 15mm(node)/10mm（extranodal）；
- •ECOG performance status 0-2；
- •Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN；
- •Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)
- •Estimated survival time ≥3 months
- •Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study.
排除标准
- •Accepted major surgery within 4 weeks before treatment;
- •Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
- •Previous history of indolent lymphoma;
- •Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
- •History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
- •Requires treatment with a strong/medium CYP3A inducer;
- •The previous use of anthracycline-based drugs > 150 mg/m2;
- •Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
- •HIV infection and/or active hepatitis B or active hepatitis C;
- •Uncontrolled systemic infection;
- •Pregnant or breasting-feeding women;
- •According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.
研究组 & 干预措施
Patients receiving Pola+ZR-CHP treatment
干预措施: Polatuzumab Vedotin (Drug)
Patients receiving Pola+ZR-CHP treatment
干预措施: Zanubrutinib (Drug)
Patients receiving Pola+ZR-CHP treatment
干预措施: Rituximab (Drug)
Patients receiving Pola+ZR-CHP treatment
干预措施: Cyclophosphamide (Drug)
Patients receiving Pola+ZR-CHP treatment
干预措施: Doxorubicin (Drug)
Patients receiving Pola+ZR-CHP treatment
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression-free Survival（PFS）
时间窗: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death
次要结局
- Overall Survival(From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.)
- Adverse Events(AEs)(From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.)
- Duration of Response（DOR）(All time in the study)
- Objective Response rate（ORR）(From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.)
- Complete Response（CR）(From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.)