A Phase II Study Of Daunomycin And ARA-C, Both Given By Continous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 98
- 主要终点
- CR
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. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.
详细描述
OBJECTIVES:
- Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover.
Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients receive a second course of consolidation chemotherapy.
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:
- •Histologically confirmed acute myeloid leukemia (AML)
- •No M3 AML or blastic transformation of chronic myelogenous leukemia
- •Must be enrolled on SWOG-9007 and S9910 protocols
- •PATIENT CHARACTERISTICS:
- •56 and over
- •Performance status:
- •Zubrod 0-3
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 4 times ULN
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance greater than 40 mL/min
- •Cardiovascular:
- •LVEF at least 50% by MUGA scan or 2-dimensional echocardiogram
- •No unstable cardiac arrhythmias
- •No unstable angina
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior systemic chemotherapy for acute leukemia
- •Prior hydroxyurea to control high cell counts allowed
- •Prior low-dose cytarabine (less than 100 mg/m^2/day) for treatment of myelodysplastic syndrome allowed
- •At least 30 days since prior chemotherapy and recovered
- •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
CR
时间窗: After induction therapy is completed
次要结局
未报告次要终点