NCT00066794已完成2 期
A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 97
- 主要终点
- Complete remission (CR)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients with previously untreated acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in these patients.
- Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen.
- Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover. Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy.
- Consolidation therapy: Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Morphologically confirmed acute myeloid leukemia (AML)
- •Differential diagnosis of AML based on FAB classification system
- •M0-M7 (No M3)
- •No blastic transformation of chronic myelogenous leukemia
- •Must be currently registered on protocols SWOG-9007 and SWOG-S9910
- •PATIENT CHARACTERISTICS:
- •56 and over
- •Performance status
- •Zubrod 0-3 (for patients 56 to 60 years of age) OR
- •Zubrod 0-2 (for patients 61 to 70 years of age) OR
- •Zubrod 0-1 (for patients 71 years of age and over)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
- •AST and/or ALT no greater than 4 times ULN
- •Creatinine no greater than 1.5 times ULN AND/OR
- •Creatinine clearance greater than 40 mL/min
- •Cardiovascular
- •Left ventricular function normal
- •Ejection fraction at least 50% by MUGA or echocardiogram
- •No unstable cardiac arrhythmias
- •No unstable angina
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent pegfilgrastim
- •Chemotherapy
- •At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for myelodysplastic syndromes and recovered
- •Prior hydroxyurea to control high cell counts allowed
- •No prior systemic chemotherapy for acute leukemia
- •Concurrent single-dose intrathecal chemotherapy allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Complete remission (CR)
时间窗: After induction therapy is completed
次要结局
未报告次要终点
研究者
研究点 (97)
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