NCT00268229已完成1 期
A Phase I Trial of Imatinib Mesylate (Gleevec, Formerly Known as STI571) in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of imatinib mesylate at one year
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin and cytarabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) and recommended phase II dose of imatinib mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with relapsed acute myeloid leukemia.
Secondary
- Assess the non-dose-limiting toxicities associated with this regimen in these patients.
- Determine any preliminary evidence of clinical activity of this regimen in these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Bone marrow biopsy confirming acute myeloid leukemia (AML)
- •No M3 AML
- •Patient must have relapsed to standard chemotherapy
- •Patients who relapse within six months of response to treatment or those who never responded to an anthracycline/cytarabine combination will be excluded
- •At least 20% of peripheral blood or bone marrow blasts positive for c-kit
- •No evidence of leptomeningeal involvement
- •PATIENT CHARACTERISTICS:
- •ECOG Performance Status 0-2
- •Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal
- •Serum creatinine ≤ 2 times upper limit of normal
- •No New York Heart Association grade III or IV cardiac problems
- •Defined as congestive heart failure or myocardial infraction within the past 6 months
- •No known chronic liver disease (i.e., chronic active hepatitis and cirrhosis)
- •No serious or poorly controlled medical conditions that could be exacerbated by the treatment or would seriously complicate compliance with this study
- •No other active primary malignancy unless it is not currently clinically significant and does not require active intervention
- •No history of HIV infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No significant history of noncompliance to medical regimens or inability to grant reliable informed consent
- •PRIOR CONCURRENT THERAPY:
- •Previous treatment-related toxicities should be resolved
- •No other investigational agents within the past 28 days
- •No chemotherapy within the past 4 weeks
- •6 weeks for nitrosourea or mitomycin C
- •No major surgery within the past 4 weeks
- •No concurrent use of the following drugs is allowed: ketoconazole, dilantin, itraconazole, erythromycin, clarithromycin, dexamethasone, rifampin, tegretol, phenobarbital, Hypericum perforatum (St. John's wort), cyclosporine, pimozide, warfarin, certain HMG-CoA reductase inhibitors, traizolo-benzodiazepines, or dihydropyridine calcium channel blockers
- •No other concurrent anticancer agents, including chemotherapy and biologic agents
- •No other concurrent investigational drugs
- •Concurrent medications known to be metabolized by cytochrome p450 enzymes are allowed
- •No therapeutic anticoagulation with warfarin will be permitted in patients participating in this study
- •Therapeutic anticoagulation may be accomplished using low-molecular weight heparin
- •Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
- •No concurrent routine use of systemic corticosteroid therapy
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of imatinib mesylate at one year
时间窗: 1 year
次要结局
- Non-dose limiting toxicities associated with imatinib mesylate at one year(1 year)
研究者
研究点 (2)
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