NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
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.
研究概览
详细说明
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).
To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.
1.2 Biologic aims
To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.
To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.
To secure storage of biological material from diagnosis for future biologic studies
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Aarhus、丹麦、8200
- Department of Pediatrics, Aarhus University Hospital Skejby
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Copenhagen、丹麦、2100
- Rigshospitalet
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- AML as defined by the diagnostic criteria,
- Age < 19 years at time of study entry,
- Written informed consent
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Gemtuzumab 5 mg / m2 two courses with three week interval
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Two courses of Gemtuzumab vs. no further therapy
其他名称:
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无干预:2
No further therapy
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
无事件生存
大体时间:5年
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5年
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次要结果测量
结果测量 |
大体时间 |
---|---|
总生存期
大体时间:5年
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5年
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合作者和调查者
调查人员
- 学习椅:Henrik Hasle, MD、Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark
出版物和有用的链接
一般刊物
- Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Zeller B, Gustafsson G; Nordic Society of Pediatric Hematology and Oncology (NOPHO); AML Study Group. Long-term results in children with AML: NOPHO-AML Study Group--report of three consecutive trials. Leukemia. 2005 Dec;19(12):2090-100. doi: 10.1038/sj.leu.2403962.
- Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Gustafsson G. Treatment stratification based on initial in vivo response in acute myeloid leukaemia in children without Down's syndrome: results of NOPHO-AML trials. Br J Haematol. 2003 Jul;122(2):217-25. doi: 10.1046/j.1365-2141.2003.04418.x.
- Hasle H, Abrahamsson J, Forestier E, Ha SY, Heldrup J, Jahnukainen K, Jonsson OG, Lausen B, Palle J, Zeller B; Nordic Society of Paediatric Haematology and Oncology (NOPHO). Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004. Blood. 2012 Aug 2;120(5):978-84. doi: 10.1182/blood-2012-03-416701. Epub 2012 Jun 22.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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