Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 3 期
- 入组人数
- 258
- 试验地点
- 6
- 主要终点
- 2-year overall survival rate
研究概览
简要总结
The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
详细描述
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.
Primary Outcome Measures:
• 2-year overall survival rate
Secondary Outcome Measures:
- 2-year progression free survival rate
- overall response rate
- safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
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
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
- •New-diagnosed and untreated;
- •Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
- •Ann Arbor stage I to stage IV disease;
- •Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
- •Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- •Presence of Grade III nervous toxicity with two weeks;
- •New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
- •Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
- •CNS or meningeal involvement;
- •Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
- •Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
- •Active and severe infectious diseases;
- •Major surgery within three weeks;
- •Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
- •In any conditions which investigator considered ineligible for this study.
- •Known sensitivity or allergy to investigational Product.
研究组 & 干预措施
R-GemOx
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
干预措施: Rituximab (Drug)
R-GemOx
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
干预措施: Gemcitabine (Drug)
R-GemOx
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
干预措施: Oxaliplatin (Drug)
R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
干预措施: Rituximab (Drug)
R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
干预措施: Cyclophosphamide (Drug)
R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
干预措施: Epirubicin Injectable Product (Drug)
R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
干预措施: Vindesine (Drug)
R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
干预措施: Prednisone (Drug)
结局指标
主要结局
2-year overall survival rate
时间窗: One year
from the date of inclusion to date of death, irrespective of cause
次要结局
- 2-year progression free survival rate(One year)
- overall response rate(One year)
研究者
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University