A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 31
- 试验地点
- 20
- 主要终点
- Conventional Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.
详细描述
OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic remission, partial hematologic remission, hematologic improvement, partial response, or back to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated with troxacitabine. II. Determine the proportion of patients whose disease returns to chronic phase and remains at that level for at least 3 months when treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the duration of survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until relapse.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.
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
- 16 Years 至 120 Years（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
研究组 & 干预措施
troxacitabine
干预措施: troxacitabine (Drug)
结局指标
主要结局
Conventional Response Rate
时间窗: Week 64
Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).
次要结局
- Survival Duration(Throughout the study period of approximately 15 months.)
- Percent of Patients Returning to Chronic Phase(Throughout the study period of approximately 15 months.)
- Toxicity Profile(Every 4 weeks throughout the study period of approximately 15 months.)