A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Overall response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying giving gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone together with rituximab to see how well it works in treating patients with newly diagnosed diffuse large B-cell lymphoma.
详细描述
OBJECTIVES:
- To determine whether rituximab, in combination with non-cardiotoxic chemotherapy comprising gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, is efficacious in a group of patients who are unfit for CHOP chemotherapy.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8; cyclophosphamide IV, vincristine sulfate IV, and rituximab IV on day 1; and oral prednisolone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
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
- 18 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
- 未提供
研究组 & 干预措施
R-GCVP
Up to 6 x 21 day cycles of R-GCVP:
- Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
- Cyclophosphamide 750mg/m^2 day 1
- Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
- Prednisolone 100mg/day days 1-5
- Rituximab 375mg/m^2 day 1
- Neulasta 6mg day 9
干预措施: rituximab (Biological)
R-GCVP
Up to 6 x 21 day cycles of R-GCVP:
- Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
- Cyclophosphamide 750mg/m^2 day 1
- Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
- Prednisolone 100mg/day days 1-5
- Rituximab 375mg/m^2 day 1
- Neulasta 6mg day 9
干预措施: cyclophosphamide (Drug)
R-GCVP
Up to 6 x 21 day cycles of R-GCVP:
- Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
- Cyclophosphamide 750mg/m^2 day 1
- Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
- Prednisolone 100mg/day days 1-5
- Rituximab 375mg/m^2 day 1
- Neulasta 6mg day 9
干预措施: gemcitabine hydrochloride (Drug)
R-GCVP
Up to 6 x 21 day cycles of R-GCVP:
- Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
- Cyclophosphamide 750mg/m^2 day 1
- Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
- Prednisolone 100mg/day days 1-5
- Rituximab 375mg/m^2 day 1
- Neulasta 6mg day 9
干预措施: prednisolone (Drug)
R-GCVP
Up to 6 x 21 day cycles of R-GCVP:
- Gemcitabine 750mg/m^2 days 1 & 8 (increasing to 875mg/m^2 for cycle 2 & 1g/m^2 for subsequent cycles if tolerated satisfactorily)
- Cyclophosphamide 750mg/m^2 day 1
- Vincristine 1.4mg/m^2 day 1 (capped at 2mg)
- Prednisolone 100mg/day days 1-5
- Rituximab 375mg/m^2 day 1
- Neulasta 6mg day 9
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Overall response rate
时间窗: End of treatment
次要结局
- Toxicity(End of treatment)
- Progression-free survival(Not specified in protocol)
- Overall survival(Not specified in protocol)