Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed AML
排除标准
- •children with Down's syndrome and acute promyelocytic leukemia (APL)
研究组 & 干预措施
CAMS-2005 trial
The induction course was Daunorubicin(DNR) + Cytarabine(Ara-C) or Homoharringtonine(HHT) + Ara-C or HHT + DNR + Ara-C. There are 5 consolidation course after complete remission (CR).
CAMS-2009 trial
The induction course was MAE(Mitoxantrone + Cytarabine + Etoposide) or IAE(Idamycin + Cytarabine + Etoposide). Risk-stratified therapy and dose-dense intensive chemotherapy were adopted in the consolidation therapy. After the second course of therapy, patients in remission were stratified into three risk groups: low-risk children were defined as those with t(8;21) and a white blood cell count lower than 50,000/L, inv(16), or an age younger than 2 years without any high-risk factors; high-risk children were those with CR after consolidation course 1 or induction C , or with abnormalities of monosomy 7, 5q-, t(16;21), t(9;22)(Philadelphia chromosome [Ph1]); intermediate-risk children were those who were not in either a low-risk or high-risk group. Hematopoietic stem cell transplantation (HSCT) was indicated for only relapsed patients in the second CR.
干预措施: Risk-stratified therapy (Other)
结局指标
主要结局
overall survival (OS)
时间窗: From date of diagnosed until the date of death from any cause, assessed up to 60 months
overall survival
event-free survival (EFS)
时间窗: From date of diagnosed until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
event-free survival
complete remission (CR)
时间窗: through study completion, an average of 1 year
fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
次要结局
未报告次要终点
研究者
Zhu Xiaofan
Director
Institute of Hematology & Blood Diseases Hospital, China