NCT07299331
尚未招募
不适用
A Multicenter, Single-Arm, Prospective Clinical Study of Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma
未提供0 个研究点目标入组 50 人开始时间: 2026年1月1日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- CRR
概览
简要总结
The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies.
Participants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years
- •Histologically confirmed MZL in untreated stage III or IV and needed for therapy as determined by the treating physician
- •ECOG performance status 0-2
- •Expected survival ≥ 6 months
- •Adequate hematologic and organ function: absolute neutrophil count ≥1,000/mm3 (independent of growth factor support), platelet counts ≥75,000/mm3, serum aspartate transaminase or alanine transaminase less than 2.5 times the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, and bilirubin ≤1.5×ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of nonhepatic origin, in which case bilirubin should not exceed 3 g/dL, left ventricular ejection fraction (LVEF) of the heart≥ 50%
- •Women of childbearing potential and men who were sexually active were required to be practicing a highly effective method of birth control during and after the study
- •No history of other malignant tumors
- •At least one measurable lesion with a longest diameter of ≥ 1.5 cm or measurable lesions of extranodal lesions ≥ 1.0 cm.
- •Able to understand the study and provide signed Informed Consent Form
排除标准
- •Pregnant or lactating women
- •Active central nervous system lymphoma
- •Previous anti-tumor treatment
- •A severe immediate-type hypersensitivity reaction history for any of the drugs used in this study
- •History of stroke or intracranial hemorrhage within 6 months before study entry
- •Received a live attenuated vaccine within 4 weeks prior to enrollment History of human immunodeficiency virus, or active hepatitis C virus, or active hepatitis B virus infection, or any uncontrolled active systemic infection
- •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- •Other serious medical conditions that might have an impact on this study
研究组 & 干预措施
Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
Experimental
干预措施: Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma (Drug)
Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
Experimental
干预措施: Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma (Drug)
结局指标
主要结局
CRR
时间窗: 2 years
Complete remission rate
次要结局
- ORR(2 years)
- 2 year-progress free survival rate(2 years)
- TTR(From randomization up to 24 months post-randomization)
- DoR(From the date of first confirmed CR/PR up to 24 months post-confirmed response)
- OS(From randomization up to 24 months post-randomization)
- Incidence rate of adverse events(2 years)
研究者
Mingzhi Zhang
Chief Physician
The First Affiliated Hospital of Zhengzhou University
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