A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The Rate of Major Cytogenetic Response at 6 Months
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. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30-60 days.
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 120 Years（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
Cytarabine/ Imatinib Mesylate
干预措施: cytarabine (Drug)
Cytarabine/ Imatinib Mesylate
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
The Rate of Major Cytogenetic Response at 6 Months
时间窗: 6 months
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
次要结局
- The Rate of Complete Cytogenetic Response at 6 Months(6 months)
- The Rate of Complete and Major Cytogenetic Responses at 12 Months(12 months)
- The Rate of Minor Cytogenetic Responses at 6 and 12 Months(6 and 12 months)
- The Rate of Complete Hematologic Responses at 6 and 12 Months(6 and 12 months)