Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 81
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the response rate, progression-free survival, and overall survival of patients with previously untreated aggressive CD20+ B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide, vincristine, prednisone, and cyclophosphamide.
- Determine the toxic effects of this regimen in these patients.
- Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression with complete response rate, progression-free survival, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2 additional courses.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: filgrastim (Biological)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: rituximab (Biological)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: cyclophosphamide (Drug)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: doxorubicin hydrochloride (Drug)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: etoposide (Drug)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: prednisone (Drug)
EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Response
时间窗: 5 months
次要结局
- Progression free Survival(Study entry to progression or tx related death)
- Overall survival(Study entry to death from any cause)
- Toxicity(q 2cycles on Tx, then q 6 mon for 2 yrs, then at relapse)