Phase II Study of Arsenic Trioxide (NSC #706363) Therapy for Fludarabine Refractory or Relapsed Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine.
详细描述
OBJECTIVES: I. Determine the clinical efficacy and safety of arsenic trioxide in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine or in relapse. II. Determine the pattern of clinical adverse experience in these patients when treated with this regimen. III. Evaluate the effects of this drug on cytokines, apoptosis, and angiogenesis in these patients.
OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5, 8-12, and 15-19. Courses repeat with 2 to 5 week intervals between courses for 10-12 courses (about 1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供