Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 试验地点
- 32
- 主要终点
- Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy 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. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Determine the dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride in pediatric patients with acute lymphoblastic leukemia (ALL).
- Determine whether it is possible to reduce therapy in pediatric patients with low-risk ALL and a PVA (prednisolone-vincristine-asparaginase) score of 3+4 without loss of efficacy.
- Investigate the role of single nucleotide polymorphisms of infection defense gene for infectious complications during therapy in these patients.
- Reduce neurological complications by reducing doses of intrathecal methotrexate.
- Reduce allergic reactions against asparaginase (ASP) by using pegaspargase after E. coli ASP.
OUTLINE: This is a randomized, multicenter study.
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Prephase: Patients are randomized to 1 of 3 treatment arms.
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Arm I: Patients receive doxorubicin hydrochloride IV once.
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Arm II: Patients receive daunorubicin hydrochloride IV once.
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Arm III: Patients receive daunorubicin hydrochloride IV once at a higher dose than in arm II.
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Induction phase: All patients receive vincristine IV 4 times weekly, daunorubicin hydrochloride IV 3 times weekly, and oral prednisolone daily for 4 weeks.
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Intensive phase: Patients are stratified according to risk (low vs high).
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
Reduce therapy in low-risk patients without loss of efficacy
Reduce neurological complications
Reduce allergic reactions against asparaginase
次要结局
未报告次要终点