NCT01990807Unknown4 期
Philadelphia -Negative High-risk Children Acute Lymphoblastic Leukemia(ALL) Treatment:Induction Therapy:Vincristine(V),Idarubicin(I),L-asparaginase(L),Dexamethasone(D);Consolidation:V+Daunorubicin(D)+L+D, Methotrexate,Cytarabine
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The event free survival of high risk ALL
研究概览
简要总结
The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in some high risk groups, The prognosis of patients is still very bad and the relapse rate is high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.
详细描述
- The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased.
- Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome.
- The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with high-risk ALL Children lower than 18years old
排除标准
- •Bcr/Abl(+) Children with middle-risk or standard-risk ALL
研究组 & 干预措施
Idarubicin(IDA)
Active Comparator
philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times
干预措施: Idarubicin(IDA) (Drug)
结局指标
主要结局
The event free survival of high risk ALL
时间窗: 2 years
次要结局
- The relapsed rate, death, overall survival(2 years)
研究者
Xiaofan Zhu
chief physician
Chinese Academy of Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in ChildrenChildAcute Lymphoblastic LeukemiaNCT02339350The Korean Society of Pediatric Hematology Oncology110
已完成
不适用
Childhood Acute Lymphoblastic Leukaemia: Follow-UpPrecursor Cell Lymphoblastic Leukemia-LymphomaRecurrenceNCT03545659University of Aarhus277
招募中
不适用
Advanced Translational Research on Childhood LeukemiaChildhood LeukemiaNCT04478006Chinese University of Hong Kong300
招募中
不适用
Mercaptopurine Therapeutic Drug Monitoring to Optimize the Maintenance Phase of Childhood ALLAcute Lymphoblastic LeukemiaNCT05811845IRCCS Burlo Garofolo250
Unknown
不适用
Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEALeukaemia During Childhood or AdolescenceNCT01756599Assistance Publique Hopitaux De Marseille2,900