Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete and partial response
研究概览
简要总结
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
详细描述
OBJECTIVES:
I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.
OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed chronic myelogenous leukemia
- •Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
- •Accelerated or non-lymphoid blastic phase
- •Performance status - ECOG 0-2
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST no greater than 2 times ULN
- •Creatinine less than 2.0 mg/dL
- •Normal cardiac function
- •No New York Heart Association class III or IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior decitabine
- •At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
- •Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
- •Prior imatinib mesylate allowed
- •Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
- •No concurrent grapefruit or grapefruit juice
排除标准
- 未提供
研究组 & 干预措施
Treatment (imatinib mesylate, decitabine)
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: imatinib mesylate (Drug)
Treatment (imatinib mesylate, decitabine)
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: decitabine (Drug)
Treatment (imatinib mesylate, decitabine)
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete and partial response
时间窗: 6 months
Hematologic improvement
时间窗: Up to 1 year
Duration of response
时间窗: Date of documented response until relapse, assessed up to 4 years
次要结局
- Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0(Up to 4 years)