NCT00086775已完成2 期
Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Compare the complete response rate in patients with refractory or relapsed B-cell chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine and rituximab.
Secondary
- Compare the overall response rate in patients treated with these regimens.
- Compare 1-year survival of patients treated with these regimens.
- Compare time to progression in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Compare the adverse event profile of these regimens in these patients.
- Compare the molecular response rate in patients treated with these regimens.
- Compare lymphocyte and lymphocyte subset recovery (CD3, CD3/CD4, CD3/CD8, CD20) in patients treated with these regimens.
- Compare the time to complete response in patients treated with these regimens.
- Compare the rate of cytomegalovirus reactivation and time to reactivation in patients treated with these regimens.
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:
- •Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as:
- •Peripheral lymphocyte count > 5,000/mm^3
- •Clonal CD5-, CD19-, and CD23-positive lymphocytes
- •Refractory to OR relapsed after prior first-line therapy
- •No CNS involvement with CLL
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine ≤ 1.5 times ULN
- •Immunologic
- •No active cytomegalovirus
- •No prior fludarabine-associated autoimmune hemolytic anemia or immune thrombocytopenic purpura
- •No active infection requiring treatment with antibiotic, antiviral, or antifungal agents
- •No prior significant allergic reaction to antibody therapies that required therapy to be discontinued
- •HIV negative
- •No active secondary malignancy
- •No other concurrent severe diseases or mental disorders
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior alemtuzumab and/or rituximab
- •No prior bone marrow transplantation
- •No concurrent thrombopoietin or pegfilgrastim
- •Chemotherapy
- •More than 3 weeks since prior fludarabine
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 3 months since prior investigational drugs
- •No other concurrent cytotoxic therapy
排除标准
- 未提供
研究者
研究点 (10)
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