NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 32
- 主要终点
- Minimal residual disease
研究概览
简要总结
This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML as defined by the WHO diagnostic criteria
- •Age < 19 years at time of diagnosis
- •Written informed consent
排除标准
- •Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
- •AML secondary to previous bone marrow failure syndrome.
- •Down syndrome (DS)
- •Acute promyelocytic leukaemia (APL)
- •Myelodysplastic syndrome (MDS)
- •Juvenile Myelomonocytic Leukaemia (JMML)
- •Known intolerance to any of the chemotherapeutic drugs in the protocol.
- •Fanconi anaemia
- •Major organ failure precluding administration of planned chemotherapy.
- •Positive pregnancy test
- •Lactating female or female of childbearing potential not using adequate contraception
研究组 & 干预措施
Standard arm MEC and ADxE
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
干预措施: Randomisation course 1 mitoxantrone versus DaunoXome (Drug)
Standard arm MEC and ADxE
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
干预措施: Randomisation course 2 ADxE versus FLADx (Drug)
Experimental DxEC and standard ADxE
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
干预措施: Randomisation course 1 mitoxantrone versus DaunoXome (Drug)
Standard arm MEC and experimental FLADx
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
干预措施: Randomisation course 2 ADxE versus FLADx (Drug)
Experimental DxEC and experimental FLADx
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
干预措施: Randomisation course 1 mitoxantrone versus DaunoXome (Drug)
Experimental DxEC and experimental FLADx
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
干预措施: Randomisation course 2 ADxE versus FLADx (Drug)
结局指标
主要结局
Minimal residual disease
时间窗: On day 22 after the first induction and after second induction
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
次要结局
- Long-term toxicity(10 years)
- Acute toxicity(six months)
- Overall survival(Five years)
- Event-free survival(5 years)