NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Event free survival
研究概览
简要总结
The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy.
Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.
详细描述
The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:
1.1 Therapeutic aims
To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.
To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.
To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 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 diagnostic criteria,
- •Age < 19 years at time of study entry,
- •Written informed consent
排除标准
- •Previous chemo- or radiotherapy,
- •AML secondary to previous bone marrow failure syndrome,
- •Down syndrome (DS),
- •Acute promyelocytic leukemia (APL),
- •Juvenile myelomonocytic leukemia (JMML),
- •Myelodysplastic syndrome (MDS),
- •Fanconi anemia,
- •Positive pregnancy test
研究组 & 干预措施
1
Gemtuzumab 5 mg / m2 two courses with three week interval
干预措施: Gemtuzumab ozogamicin (Drug)
结局指标
主要结局
Event free survival
时间窗: 5 years
次要结局
- Overall survival(5 years)