NCT00193518已完成2 期
A Phase II Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
Additional active agents are needed to further improve the treatment of patients with CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression and is not as immunosuppressive as other available agents, it may be an additional treatment option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide in patients with relapsed or refractory CLL/SLL
详细描述
Upon determination of eligibility, patients will receive:
- Arsenic Trioxide
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •To be included in this study, you must meet the following criteria:
- •Histologically proven B-cell CLL/SLL.
- •Must have had a minimum of 1 and a maximum of 3 previous systemic regimens
- •Must have progressive CLL/SLL
- •Measurable or evaluable disease
- •ECOG performance status 0, 1, or 2
- •Age > 18 years.
- •Patients with cytopenias caused by bone marrow involvement are eligible
- •All patients must give written informed consent prior to entering this study.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Unstable active infection on the basis of neutropenia
- •Previous severe opportunistic infections
- •Severe immune mediated anemia or thrombocytopenia
- •Serious underlying medical conditions
- •Brain metastases or meningeal involvement
- •History of other neoplasms
- •Significant underlying heart dysfunction
- •Women who are pregnant or
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rate
次要结局
- Toxicity
- Progression-free survival
研究者
研究点 (2)
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