A Phase II Study of Fludarabine (F), Rituxan (R) and Avastin (A) Followed by RA Maintenance in Patients With Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, 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 and bevacizumab, 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 fludarabine phosphate together with rituximab and bevacizumab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine phosphate together with rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia that has relapsed or not responded to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To estimate PFS at 2 years after FR plus Avastin (A) induction followed by Rituximab plus Avastin (RA) maintenance therapy for relapsed/refractory CLL patients.
SECONDARY OBJECTIVES:
I. To evaluate response rates after FR-A induction and RA maintenance therapy. II. To eliminate residual disease (documented by flow cytometry and/or PCR) in patients who have achieved a CR after FR-A.
III. To estimate the rate of conversion of PR to CR after FR-A. IV. To determine the safety and pharmacokinetics of FR-A and RA maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
See Detailed Description
干预措施: fludarabine phosphate (Drug)
Arm I
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干预措施: rituximab (Biological)
Arm I
See Detailed Description
干预措施: bevacizumab (Biological)
Arm I
See Detailed Description
干预措施: laboratory biomarker analysis (Other)
Arm I
See Detailed Description
干预措施: flow cytometry (Other)
Arm I
See Detailed Description
干预措施: polymerase chain reaction (Genetic)
Arm I
See Detailed Description
干预措施: fluorescence in situ hybridization (Genetic)
结局指标
主要结局
Progression-free survival
时间窗: At 2 years
次要结局
- Response (complete, partial, or nodular partial response, progressive disease, stable disease, or minimal residual disease)(At 2 years)