Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 21, 2013
November 1, 2013
2 years
November 16, 2013
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The event free survival of high risk ALL
2 years
Secondary Outcomes (1)
The relapsed rate, death, overall survival
2 years
Other Outcomes (1)
infection rate
2 years
Study Arms (1)
Idarubicin(IDA)
ACTIVE COMPARATORphiladelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times
Interventions
6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- Children with high-risk ALL Children lower than 18years old
You may not qualify if:
- Bcr/Abl(+) Children with middle-risk or standard-risk ALL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaofan Zhu, MD
Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
November 16, 2013
First Posted
November 21, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 21, 2013
Record last verified: 2013-11