Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma: An Exploratory Small Sample, Phase II, Single-center Clinical Trail
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma.
详细描述
Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2). Rituximab is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC). These two drugs may have a synergistic effect on anti-tumor. The purpose of this study is to determine whether Toripalimab with Rituximab is effective and safe for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma. This is an exploratory small sample, phase II, single-center clinical trial, which is going to enroll 20 participants.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •According to the WHO 2016 classification criteria, the CD20 positive diffuse large B-cell lymphoma (DLBCL) diagnosed by pathology should include the indicators of immunohistochemistry: CD10, BCL-2, MUM-1, BCL-6 and C-MYC;
- •Relapsed or refractory DLBCL.Patients younger than 65 years should relapse or progress after receiving at least second-line treatment, and patients 65 years of age and older could be intolerant to second-line treatment, and they who relapse or progress after receiving first-line treatment;
- •There is at least one measurable lesion, defined as measurable dual-diameter, intra-lymph node lesion, short diameter> 1.5cm, extra-lymph node lesion short diameter> 1.0cm;
- •Recurrence confirmed by pathological biopsy and CD20 positive;
- •ECOG score 0-2 points;
- •No autoimmune diseases;
- •Blood routine examination meets the following criteria:
- •Neutrophil count ≥ 1.5 x 109 / L,;
- •Platelet ≥ 75 x 109 / L,;
- •Hemoglobin ≥ 10.0 g / dL;
- •The main organ function meets the following criteria:
- •Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper limit of normal value;
- •Bilirubin ≤ 2.0 mg / dL;
- •Creatinine clearance rate ≥ 60 mL / min;
- •Patients must agree to take effective contraceptive measures during the study according to the investigator's request;
- •Understand and voluntarily sign written informed consent.
排除标准
- •Diagnosed as transformed diffuse large B-cell lymphoma;
- •Diagnosed as double-hit diffuse large B-cell lymphoma (DHL);
- •Diagnosed as primary or secondary central nervous system lymphoma;
- •HBV DNA positive or HCV RNA positive patients;
- •Left ventricular ejection fraction <50%;
- •Patients with history of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, ankylosing spondylitis
- •Patients are using or have been used immunosuppressive drugs
- •Patients with ≥2 grade peripheral neuropathy
研究组 & 干预措施
Toripalimab combine with Rituximab
Experimental: Toripalimab combine with Rituximab
Induction period:
Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles.
Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles.
Maintenance:
Toripalimab 240mg administered intravenously (IV) and Rituximab 375mg/m² on Day 1 of each 56-day cycle for 6 cycles.
干预措施: Toripalimab combine with Rituximab (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: up to 24 months
From the beginning of treatment, adopt Lugano 2014 evaluation standard, imaging examinations are performed every 2 cycles to assess changes in disease until progression or death
Progression Free Survival(PFS)
时间窗: up to 24 months
From the date into this study to disease progression or death
次要结局
- To assessment of the safety events(up to 24 months)
- Assessment of the correlation between tumor cell PD-L1 expression intensity and efficacy(up to 24 months)
研究者
Shi Yuankai
chief physician
Chinese Academy of Medical Sciences