Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 35
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
- Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
- Determine the toxicity of this regimen in these patients.
- Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.
Patients are followed at least every 2 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Diagnosis of Waldenstrom's macroglobulinemia
- •CD20 positive by bone marrow immunohistochemistry or flow cytometry
- •Presence of monoclonal paraprotein
- •IgM level at least 2 times upper limit of normal (ULN)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 25,000/mm^3
- •Bilirubin less than 2.5 times ULN
- •SGOT less than 2.5 times ULN
- •Creatinine less than 2.5 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after study
- •No serious comorbid disease
- •No uncontrolled bacterial, fungal, or viral infection
- •No other active malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior rituximab
- •No prior nucleoside analogue therapy
- •Chemotherapy:
- •At least 30 days since prior chemotherapy
- •Endocrine therapy:
- •At least 30 days since prior steroid therapy
- •No concurrent corticosteroids
- •Radiotherapy:
- •At least 30 days since prior radiotherapy
- •Not specified
- •No more than 2 prior courses of therapy
排除标准
- 未提供