National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Response rate
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.
详细描述
OBJECTIVES:
- Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.
- Compare the time to disease progression in patients treated with these regimens.
- Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.
- Compare the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive fludarabine IV* and cyclophosphamide IV* on days 1-3.
- Arm II: Patients receive rituximab IV on day 1 and fludarabine IV* and cyclophosphamide IV* on days 2-4.
NOTE: *In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed previously untreated mantle cell lymphoma requiring therapy
- •Any stage
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)^*
- •Alkaline phosphatase no greater than 2.5 times ULN^*
- •Hepatitis B and hepatitis C negative NOTE: *Unless related to lymphoma
- •Creatinine no greater than 2.5 times ULN^* NOTE: *Unless related to lymphoma
- •No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix
- •No prior psychological illness or condition that would preclude study compliance
- •No known hypersensitivity to murine proteins
- •No concurrent uncontrolled medical conditions
- •No other illness that would severely limit life expectancy
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response rate
Time to disease progression
Toxicity
Overall survival
次要结局
未报告次要终点