NCT07514169招募中2 期
The Efficacy and Safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) Regimen in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen in older treatment-naive patients with large B-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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must satisfy all of the following criteria to be enrolled in the study:
- •Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
- •Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
- •Eastern Cooperative Oncology Group Performance Status 0-2
- •At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
- •Life expectancy of at least 3 months determined by researchers
- •The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
- •Anti-lymphoma drugs have not been used before (except glucocorticoids)
排除标准
- •Presence of any of the following criteria will exclude a patient from enrollment:
- •Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- •Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- •Neutrophils<1.0×10^9/L Platelets<75×10^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.
- •eGFR is lower than 30ml/min/1.73m^2 (according to Cockcroft-Gault Equation or MDRD Equation).
- •uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block
- •Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3 IU/ml is required before entering the group
- •Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- •HIV-infected patients
- •History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
- •Other medical conditions determined by the researchers that may affect the study
研究者
Zhao Weili
Professor and Director, Shanghai Institute of Hematology
Ruijin Hospital
研究点 (1)
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