Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma: a Prospective Multi-center Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.
详细描述
All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor ：Orelabrutinib 150mg qd，Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1， every 21-day for 1 cycle). Patients will be evaluated every 2 cycles by MRI scan during the first 6 cycles，and then the interval of investigation will be prolonged to 12 weeks. The patients who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) will receive further treatment. The patients progressed disease (PD) will withdraw from the trial and receive salvage regimens. The treatment will be continued for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up for 2 years.
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
- •Age ≥18 years old ≤75 Years old, male or female
- •Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
- •No evidence of systemic lymphoma
- •Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
- •At least one measurable lesion according to Lugano 2014 criteria
- •Adequate organ function and adequate bone marrow reserve
排除标准
- •Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- •Active HIV, HBV, HCV or treponema pallidum infection
- •Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- •Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
- •Any systemic antitumor therapy performed within 2 weeks before enrollment
- •Previous use of other BTK inhibitors or PD-1 inhibitors.
研究组 & 干预措施
orelabrutinib combined with PD-1 inhibitor
The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression.
The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment.
干预措施: orelabrutinib (Drug)
orelabrutinib combined with PD-1 inhibitor
The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression.
The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment.
干预措施: Sintilimab (Drug)
orelabrutinib combined with PD-1 inhibitor
The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression.
The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
overall response rate
时间窗: 3 weeks after the end of 4 cycles of induction (each cycle is 21 days)
ORR was calculated by the proportion of patients who achieved complete remission and partial remission.
次要结局
- 1 years progression-free survival(from the date of treatment to the subject finished his 1 years follow-up phase or the disease relapsed or the death due to lymphoma)