A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B
试验速览
- 阶段
- 3 期
- 入组人数
- 648
- 试验地点
- 12
- 主要终点
- progression free survival
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.
详细描述
The study aims to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B
- •Age>=16 y.o.,<=80 y.o.
- •No past history of malignancy
- •Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Chemotherapy before
- •Bone marrow transplantation before
- •History of malignancy
- •Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Primary cutaneous, CNS, mediastinal DLBCL
- •Other uncontrollable medical condition that may that may interfere the participation of the study
- •Lab at enrollment(unless caused by lymphoma)
- •Neutrophile<1.5*10^9/L
- •Platelet<80*10^9/L
- •Hemoglobulin<100g/L
- •ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN
- •Creatinine>1.5*ULN
- •Not able to comply to the protocol for mental or other unknown reasons
- •Pregnant or lactation
- •Active liver or biliary disease
- •If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
- •HIV infection
研究组 & 干预措施
R-CHOP-50
R-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
干预措施: R-CHOP-50 (Drug)
R-CEOP-70
R-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
干预措施: R-CEOP-70 (Drug)
R-CEOP-90
R-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
干预措施: R-CEOP-90 (Drug)
结局指标
主要结局
progression free survival
时间窗: 2 year
次要结局
- Response rate(Every 4 cycles during treatment and then every 3 months for 2 years)
- Safety as assessed using the CTCAE(Days 1 of each course and then every 3 months for 2 years)
- overall survival(2 year)