Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
- Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.
OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute myeloid leukemia
- •Previously untreated disease
- •Previous hydroxyurea and/or corticosteroids are acceptable
- •No preexisting history of a hematologic disorder
- •Myelodysplastic features allowed
- •No acute leukemia secondary to previous therapy
- •No leukemic meningitis
- •PATIENT CHARACTERISTICS:
- •Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia)
- •Creatinine < 2.0 mg/dL
- •Pregnant or lactating patients are ineligible
- •Fertile patients must use effective contraception
- •No history of or active congestive heart failure
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供