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
Overview
- Phase
- Phase 4
- Intervention
- Idarubicin(IDA)
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The event free survival of high risk ALL
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
1. The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased. 2. Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome. 3. The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.
Investigators
Xiaofan Zhu
chief physician
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Children with high-risk ALL Children lower than 18years old
Exclusion Criteria
- •Bcr/Abl(+) Children with middle-risk or standard-risk ALL
Arms & Interventions
Idarubicin(IDA)
philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times
Intervention: Idarubicin(IDA)
Outcomes
Primary Outcomes
The event free survival of high risk ALL
Time Frame: 2 years
Secondary Outcomes
- The relapsed rate, death, overall survival(2 years)