NCT06412068尚未招募2 期
A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
Sun Yat-sen University0 个研究点目标入组 32 人开始时间: 2024年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
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
- •Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
- •Predicted survival time ≥ 6 months ;
- •18-75 years ;
- •IPI score 0-3；
- •ECOG performance status 0-2 ;
- •Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
- •After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
- •WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
- •Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
- •ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;
- •Sign the informed consent.
排除标准
- •Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
- •Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
- •Women in pregnancy or lactation；
- •Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
- •The researchers believe that there are other potential risks that are not suitable for participation in this study.
研究组 & 干预措施
Patients diagnosed with PMBCL.
Experimental
干预措施: Combined anti-PD-1 and R-CHOP (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: 2 years
The proportion of patients with a PR and CR
complete remission (CR)
时间窗: 2years
次要结局
- bio-marker analysis(2 years)
- overall survival (OS)(2 years)
- progression survival (PFS)(2 years)
研究者
Hua Wang
Associate senior doctor
Sun Yat-sen University
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