A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
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. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.
详细描述
OBJECTIVES:
- Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone, etoposide, and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission.
- Compare the toxicity of these 2 regimens in these patients.
- Assess the quality of life of these patients.
OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed de novo or secondary acute myeloid leukemia (AML)
- •Prior myelodysplasia allowed
- •Refractory anemia with excess blasts (RAEB) OR
- •RAEB in transformation
- •No relapsed AML
- •No chronic granulocytic leukemia in transformation
- •No CNS disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN
- •Creatinine no greater than 2.5 times ULN
- •Cardiovascular:
- •No severe or uncontrolled cardiac failure
- •No serious medical, social, or psychological condition
- •Not HIV 1 or 2 seropositive
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No plan for future autograft
- •Chemotherapy:
- •No prior chemotherapy for myelodysplastic syndrome or AML
- •Endocrine therapy:
- •Not specifed
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent aluminum or magnesium-based antacids
排除标准
- 未提供