Low-Dose Decitabine Plus Anti-PD-1 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma With Extranodal (Esp. Central Nervous System) Involvement: A PhaseⅡClinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.
详细描述
To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14-80 years old, male or female;
- •Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement;
- •Expected survival of more than 3 months;
- •AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN;
- •Inactive infection and severe mental illness
- •ECOG score 0~2
- •According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction >50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion
- •The serum pregnancy test of female subjects must be negative
- •Signed informed consent
排除标准
- •Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors;
- •Severe uncontrolled medical disease or active infection (including HIV+);
- •Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding;
- •Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies;
- •Pregnant or nursing women;
- •Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases);
- •The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.)
- •The situation that the researcher judged was not suitable for inclusion
研究组 & 干预措施
Treatment group
Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8
干预措施: Low-Dose Decitabine plus anti-PD-1 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 1-year
ORR
次要结局
- Progression Free Survival(1-year)
- Clinical Benefit Rate(1-year)
- Time to Response(1-year)
- Duration of Remission(1-year)
- Overall Survival(1-year)
研究者
Yu Zhao
Chief physician
Chinese PLA General Hospital