NCT00754650已完成2 期
ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Bone Marrow Response
研究概览
简要总结
This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.
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
- 否
入选标准
- •Male or female patients, ≥ 18 years of age.
- •B-chronic lymphocytic leukemia not yet requiring treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy.
- •Life expectancy > 6 months.
排除标准
- •Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
- •Computed tomography (CT) scan based evidence of tumor invading major blood vessels.
- •Gastrointestinal (GI) tract involvement by CLL.
- •Active viral, bacterial, or fungal infection.
- •Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.
研究组 & 干预措施
Bevacizumab 15 mg/kg
Experimental
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Bone Marrow Response
时间窗: Baseline to the end of treatment (up to 24 weeks)
Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.
次要结局
- Best Overall Response (BOR)(Baseline to the end of treatment (up to 24 weeks))
研究者
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