A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete response rate
研究概览
简要总结
This is a prospective single arm, multi-center, real-world study to observe the efficacy and safety of ZR (Zanubrutinib combined with Rituximab) in the first-line treatment for patients with marginal zone lymphoma (MZL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology
- •First-line treatment with the combination regimen of zanubrutinib and rituximab
- •No receiving systematic treatment before enrollment
- •Having at least one measurable lesions. Measurable lesions were defined as: the longest diameter of lymph node lesions in CT cross-sectional images > 1.5 cm, or the longest diameter of the extranodal lesion is greater than 1.0cm
- •The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
排除标准
- •Other malignant tumor history or active malignant tumor need be treated
- •In addition to zanubrutinib and rituximab, other anti-tumor drug treatments were also received simultaneously (except for glucocorticoids aimed at controlling symptoms before formal treatment).
研究组 & 干预措施
Zanubrutinib Combined With Rituximab
Induction treatment:
Rituximab, 375mg/m2, Intravenous administration on day 1 (21 days/cycle); Zanubrutinib, 160mg twice daily continuous oral administration from 1 to 8 cycles (21 days/cycle)
Maintenance treatment:
Zanubrutinib, 160mg twice daily continuous oral administration for two years (28 days/cycle)
干预措施: Zanubrutinib (Drug)
Zanubrutinib Combined With Rituximab
Induction treatment:
Rituximab, 375mg/m2, Intravenous administration on day 1 (21 days/cycle); Zanubrutinib, 160mg twice daily continuous oral administration from 1 to 8 cycles (21 days/cycle)
Maintenance treatment:
Zanubrutinib, 160mg twice daily continuous oral administration for two years (28 days/cycle)
干预措施: Rituximab (Drug)
结局指标
主要结局
complete response rate
时间窗: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment
the total proportion of patients with complete response (CR)
次要结局
- objective response rate(every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment)
- progression-free survival(from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment))
- overall survival(from date of the first cycle of treatment to the date of death from any cause (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment))
- incidence and relationship with study drugs of grade 3-4 adverse events(from the date of the first cycle of treatment to 24 months after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment))
研究者
Zhihua Yao, PhD
Director
Henan Cancer Hospital