NCT07198373尚未招募不适用
Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma
Beijing GoBroad Hospital0 个研究点目标入组 40 人开始时间: 2025年9月20日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Progression-free survival (PFS) rate at 24 months post-administration
研究概览
简要总结
This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •(1) Age ≥ 18 years, no gender restrictions; (2) Expected survival time exceeding 12 weeks; (3) Cytologically or histopathologically confirmed diagnosis of non-Hodgkin B-cell lymphoma according to WHO 2016 criteria; (4) Platelet count ≥ 50 × 10⁹/L; (5) Currently undergoing or scheduled to initiate oral zanubrutinib maintenance therapy following autologous or allogeneic CAR-T cell therapy; (6) Able to understand this trial and has signed an informed consent form.
排除标准
- •(1) Pregnant or lactating individuals; male subjects planning to conceive within one year of treatment or within one year after cell reinfusion, or whose partners plan to conceive within one year after cell reinfusion; (2) Individuals with medical conditions that affect their ability to sign a written informed consent form or comply with study procedures; or those unwilling or unable to adhere to study requirements; (3) Individuals deemed unsuitable for participation in this trial by the investigator.
- •Pregnant or lactating individuals; or male subjects planning to conceive within one year of treatment or within one year after cell infusion, or whose partners plan to conceive within one year after cell infusion; (2) Individuals with medical conditions that prevent signing a written informed consent form or complying with study procedures; or those unwilling or unable to comply with study requirements; (3) Individuals deemed unsuitable for this trial by the investigator.
研究组 & 干预措施
Maintenance Therapy Group
干预措施: Maintenance Therapy Group (Drug)
结局指标
主要结局
Progression-free survival (PFS) rate at 24 months post-administration
时间窗: From date ofrandomization untilhe date of first documented progression , assessed up to 24 months
次要结局
- Overall Survival (OS)(From date of randomization untilhe date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Progression-Free Survival (PFS)(The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years)
研究者
Kai Hu
Director of the Lymphoma Department at Beijing Gao Bo Hospital
Beijing GoBroad Hospital
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