Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01990807|
Recruitment Status : Unknown
Verified November 2013 by Xiaofan Zhu, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome, Ph^1^, Absent B-cell Childhood Acute Lymphoblastic Leukemia||Drug: Idarubicin(IDA)||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
Active Comparator: Idarubicin(IDA)
philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times
6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
Other Name: darubicin, IDA, Demethoxydaunor Ubicin
- The event free survival of high risk ALL [ Time Frame: 2 years ]
- The relapsed rate, death, overall survival [ Time Frame: 2 years ]
- infection rate [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990807
|Contact: Xiaofan Zhu, MDfirstname.lastname@example.org|
|Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Xiaofan Zhu, MD +86-22-23909001 email@example.com|
|Principal Investigator: Xiaofan Zhu, MD|
|Principal Investigator:||Xiaofan Zhu, MD||Chinese Academy of Medical Sciences|