a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- primary endpoint
研究概览
简要总结
This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.
详细描述
This is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.The response will be evaluated every 2 cycles.Patients who achieved complete remission(CR) or partial remission(PR) will receive further treatment,and there are 6 cycles of RMO regimen for the induction.The patients with stable disease(SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens.After total 6 induction cycles,the investigators evaluate the efficiency again.After 6 cycles,the patients who receive CR or PR,can tolerate Autologous Hematopoietic Stem Cell Transplantation(AHSCT) will be candidates of high-dose chemotherapy and stem rescue.The patients who achieve CR or PR,cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance.The patients with SD or PD will receive salvage regimen.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;
- •Aged 18-70 years
- •Signature of informed consent;
- •At least one measurable lesion;
- •Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin<2XULN,ALT<4XULN,AST4XULN
- •The expected survival time is at least 3 months
排除标准
- •Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX
- •History of other malignancies that may affect the compliance of the research protocol or the analysis of the results
- •Severe cardiac insufficiency
- •Other antitumor treatments were used
- •Human immunodeficiency virus(HIV)antibody is positive
- •Pregnant or lactating women
- •Researchers consider if anyone not suitable for enrollment.
研究组 & 干预措施
Orelabrutinib,Rituximab and Methotrexate
Rituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle.
干预措施: Orelabrutinib,Rituximab and Methotrexate (Drug)
结局指标
主要结局
primary endpoint
时间窗: Enrollment is expected to last for two year, followed up for five years
Objective response rate(ORR) is the primary endpoint
次要结局
- secondary endpoints(Enrollment is expected to last for two year, followed up for five years)