Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Event-free Survival
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
详细描述
OBJECTIVES:
- Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in patients with B-cell leukemia or low-grade or mantle cell lymphoma.
- Determine the molecular response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52, cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or 20 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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 70 Years（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-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
干预措施: Pegfilgrastim (Biological)
R-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
干预措施: Rituximab (Biological)
R-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Event-free Survival
时间窗: 5 years
Percentage of participants alive without disease relapse.
Engraftment
时间窗: Up to 43 days
Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.
Non-relapse Mortality
时间窗: 5 years
Number of participants who died for reasons related to protocol treatment.
次要结局
未报告次要终点