A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL
详细描述
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety.
Primary Outcome Measures:
- overall response rate
Secondary Outcome Measures:
- progression free survival
- overall survival
- safety and toxicity
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration;
- •Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification;
- •Presence of Grade III nervous toxicity over two weeks;
- •Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;
- •Concomitant malignancy other than DLBCL requiring treatment;
- •Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial;
- •Contraindication to any drug in this regimen;
- •Active and severe infectious diseases, such as severe pheumonia or septicaemia;
- •Major surgery within three weeks;
- •Any medical, psychological or social conditions which might interfere with the investigators' assessment
- •In any conditions which investigator considered ineligible for this study.
研究组 & 干预措施
Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)
干预措施: R-GemOx (Drug)
结局指标
主要结局
overall response rate
时间窗: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
overall response rate after 3 cycles and at the end of R-GemOx regimen.
次要结局
- progression free survival(Two-year)
- overall survival(Two-year)
- The incidence and severity of adverse events(Up to 30 days following the last dose of study drug)
研究者
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University