A Retrospective Case-control Study of Newly-diagnosed Primary Central Nervous System Lymphoma (PCNSL) Treated With Methotrexate (MTX)-Based Chemotherapy in Combination With Orelabrutinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study was a single-centre, retrospective study that retrospectively collected first-line PCNSL patients receiving methotrexate-based chemotherapy ± orelabrutinib at Huashan Hospital of Fudan University. The study was divided into two retrospective cohorts, Cohort A was a cohort of patients receiving methotrexate-based chemotherapy alone, and Cohort B was a cohort of patients receiving methotrexate-based chemotherapy + orelabrutinib.
详细描述
The study was divided into two retrospective cohorts of approximately 35-40 patients each. Cohort A was the cohort of patients who received methotrexate-based chemotherapy alone, and cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib. Statistical analyses such as propensity score analysis (PSM) and inverse probability weighted (IPTW) analysis were performed, focusing on comparing and analysing the short-term efficacy data (ORR, CR) and long-term efficacy data (PFS, OS) of the two cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Pathologically confirmed primary central nervous system lymphoma
- •Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients
排除标准
- •Patients receiving ≤2 cycles of treatment without efficacy evaluation
- •Those with uncontrolled or significant cardiovascular disease, including: uncontrolled diabetes mellitus, severe cardiac, pulmonary, hepatic, renal insufficiency) and haematological, endocrine system lesions, history of other uncontrollable malignancies
研究组 & 干预措施
Cohort B
cohort B was the cohort of patients who received methotrexate-based chemotherapy + orelabrutinib.
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At the end of induction therapy, Cycle 6-8 (each cycle is 28 days)
ORR is defined as the proportion of patients with a best response of CR, CRu or PR during induction therapy
次要结局
- PFS(Up to 2 years)