IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 23
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 regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Compare the efficacy of idarubicin vs mitoxantrone in induction and first intensification in terms of achieving and maintaining complete remissions in children with acute myeloid leukemia or myelodysplastic syndrome.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and disease type (de novo acute myeloid leukemia (AML) vs AML secondary to myelodysplastic syndrome (MDS) vs MDS).
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Induction: Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive cytarabine (ARA-C) IV continuously on days 1 and 2 and then IV over 30 minutes every 12 hours on days 3-8, mitoxantrone IV on days 3-5, etoposide (VP-16) IV over 1 hour on days 6-8, and ARA-C intrathecally (IT) on days 1 and 8.
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Arm II: Patients receive ARA-C and VP-16 as in arm I and idarubicin IV on days 3-5.
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
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed acute myeloid leukemia (AML) based on the cytological, cytochemical, and immunological criteria of the FAB classification
- •Must meet 1 of the following criteria:
- •More than 30% blasts in marrow (calculation based on the total number of nucleated cells except lymphocytes and plasmocytes)
- •Presence of granulocytic sarcoma (chloroma)
- •Disease must be associated with at least 1 of the following:
- •More than 3% myeloperoxidase- or Sudan black-positive blasts
- •More than 3% platelet peroxidase-positive blasts
- •More than 20% esterase-positive blasts
- •Immunological markers compatible with a myeloid differentiation, including 1 of the following criteria:
- •Blasts positive for myeloid-associated antigen and negative for B- or T-lymphocyte antigens
- •Blasts positive for at least 2 myeloid antigens (except CD3 and CD8)
- •A cytogenetic abnormality associated with AML OR
- •Newly diagnosed myelodysplastic syndrome (MDS) based on the cytological and cytochemical criteria of the FAB classification
- •Eligible subtypes:
- •Refractory anemia with excess blasts (RAEB)
- •RAEB in transformation
- •Chronic myelomonocytic leukemia
- •No promyelocytic leukemia (M3 or M3v) treated with tretinoin (protocol EORTC-06915)
- •No AML secondary to hematologic or malignant disease other than MDS
- •Registration must occur within 48 hours of diagnosis
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •No uncontrolled bleeding disorder
- •Not specified
- •No renal failure
- •Cardiovascular:
- •No congenital heart disease
- •No encephalopathy
- •No genetic disorders
- •No uncontrolled infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No prior antileukemic therapy
排除标准
- 未提供