Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.
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
- 14 Years 至 75 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, complete response after 4 cycles of standard R-CHOP21
- •Age>=14 y.o.,<=75 y.o.
- •non-bulky (largest diameter <7.5cm)
- •ECOG =0-1
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Chemotherapy before
- •Stem cell transplantation before
- •History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Primary cutaneous, CNS 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
- •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
6R-CHOP+2R
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Rituximab (Drug)
6R-CHOP+2R
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Cyclophosphamide (Drug)
6R-CHOP+2R
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Epirubicin (Drug)
6R-CHOP+2R
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Vincristine (Drug)
6R-CHOP+2R
6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Prednisone (Drug)
4R-CHOP+4R
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Rituximab (Drug)
4R-CHOP+4R
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Cyclophosphamide (Drug)
4R-CHOP+4R
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Epirubicin (Drug)
4R-CHOP+4R
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Vincristine (Drug)
4R-CHOP+4R
4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2-year
次要结局
- Complete Response rate(21 days after 8 cycles of treatment（each cycle is 21 days）)
- Overall survival(2-year)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years)