A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 32
- 主要终点
- Overall response rate as measured by NCI Response Criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia.
- Determine the overall response rate, defined as complete or partial remission, in these patients.
Secondary
- Determine the proportion of patients with undetectable minimal residual disease.
- Determine the 2-year progression-free survival of these patients.
- Determine the 2-year overall survival of these patients.
- Determine the toxicity of this regimen.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic lymphocytic leukemia requiring therapy
- •Previously treated with ≥ 1 chemotherapeutic regimen
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Creatinine clearance ≥ 30 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment
- •Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- •No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies
- •No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy)
- •No active infection
- •No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride
- •No prior rituximab, either alone or in combination with chemotherapy
排除标准
- 未提供
结局指标
主要结局
Overall response rate as measured by NCI Response Criteria
次要结局
- Proportion of patients with undetectable minimal residual disease
- Progression-free survival at 2 years
- Overall survival at 2 years
- Toxicity