Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia
Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome, Ph^1^, Absent; B-cell Childhood Acute Lymphoblastic Leukemia
Intervention: Idarubicin(IDA) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chinese Academy of Medical Sciences Official(s) and/or principal investigator(s): Xiaofan Zhu, MD, Principal Investigator, Affiliation: Chinese Academy of Medical Sciences
Overall contact: Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The event free survival of high risk ALL
Secondary outcome: The relapsed rate, death, overall survival
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.
Eligibility
Minimum age: 6 Months.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses, Tianjin, Tianjin 300020, China; Recruiting Xiaofan Zhu, MD, Phone: +86-22-23909001, Email: xfzhu1981@126.com Xiaofan Zhu, MD, Principal Investigator
Additional Information
Starting date: October 2012
Last updated: November 20, 2013
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