First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- CRR
研究概览
简要总结
Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma。The majority of refractory patients have PD-L1 expression due to P53 mutations, some of which account for about 10% of DLBCL.Our department has found that in refractory DLBCL with high PD-L1 expression, cedilizumab monotherapy is also more effective and has reversed chemotherapy resistance.The aim of this study was to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.
详细描述
This study is a randomized, open, multicenter clinical study to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.In this study, patients with P53 mutation with PD-L1 expressing DLBCL were selected to be randomised 1:1 into 2 groups: group A Sindilizumab + R-CHOP and group B R-CHOP. Sindilizumab was administered on day 10 after chemotherapy to avoid interference from prednisone.At the end of 6 cycles, Group A treatment effective maintenance treatment with Sindilizumab for 6 months as indicated.Each patient's tumour tissue was tested for mutations and ctDNA after allocation, and ctDNA and peripheral blood free PD-L1 levels were monitored dynamically during and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages≥18 years, ≤ 80 years.
- •Patients with primary treatment of DLBCL.
- •Histopathologically confirmed diagnosis of diffuse large B-cell lymphoma.
- •At least one measurable lesion according to the 2014 Lugano criteria.
- •ECOG physical status score of 0, 1 or
- •Laboratory tests meet the following criteria unless judged to be due to lymphoma:
- •Routine blood tests: (in the absence of growth factor support therapy or blood transfusion within 7 days) haemoglobin ≥ 90 g/L, absolute neutrophil value ≥ 1.5 x 109/L, platelet count ≥ 90 x 109/L.
- •Liver biochemistry: serum creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; glutamate transaminase and glutamic oxalacetic transaminase ≤ 2.5 x upper limit of normal.
- •Coagulation: INR and APTT ≤ 2.5 times the upper limit of normal values.
- •Consent to use contraception during the trial and for 3 months after its completion.
- •Expected survival ≥ 3 months.
排除标准
- •Suffering from other untreated malignant tumours.
- •Cardiovascular disease that remains unstable under pharmacological control .
- •With severe interstitial lung disease.
- •With cognitive impairment.
- •Patients with uncontrolled autoimmune disease.
- •Presence of uncontrolled active infection.
- •Expected survival time < 3 months.
- •Lactating women and subjects of childbearing age who do not wish to use contraception.
- •With poor adherence or unable to follow up regularly.
研究组 & 干预措施
A: PD-1+R-CHOP
After one cycle of standard R-CHOP chemotherapy, Group A uses Sindilizumab + R-CHOP, with Sindilizumab administered on day 10 post-chemotherapy, scheduled for 5 cycles. After 5 cycles, CR patients in group A continue Sindilizumab treatment for 8 times, once every 21 days.
干预措施: Sintilimab (Drug)
A: PD-1+R-CHOP
After one cycle of standard R-CHOP chemotherapy, Group A uses Sindilizumab + R-CHOP, with Sindilizumab administered on day 10 post-chemotherapy, scheduled for 5 cycles. After 5 cycles, CR patients in group A continue Sindilizumab treatment for 8 times, once every 21 days.
干预措施: Rituximab (Drug)
B: R-CHOP
After one cycle of standard R-CHOP chemotherapy, Group B uses R-CHOP and plans for 5 cycles. CR patients in group B are followed up for observation.
干预措施: Rituximab (Drug)
结局指标
主要结局
CRR
时间窗: 1 year
To assess complete response rate (CRR)
次要结局
- PFS(1 year)
- OS(1 year)
- ORR(1 year)
研究者
sunxiuhua
Chief physician
Innovent Biologics (Suzhou) Co. Ltd.