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Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT01990807
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Oct 1, 2012
Anticipated Primary Completion Date :
Oct 1, 2014
Anticipated Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Idarubicin(IDA)

philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times

Drug: Idarubicin(IDA)
6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
Other Names:
  • darubicin, IDA, Demethoxydaunor Ubicin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The event free survival of high risk ALL [2 years]

    Secondary Outcome Measures

    1. The relapsed rate, death, overall survival [2 years]

    Other Outcome Measures

    1. infection rate [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Children with high-risk ALL Children lower than 18years old

    Exclusion Criteria:

    Bcr/Abl(+) Children with middle-risk or standard-risk ALL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses Tianjin Tianjin China 300020

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Xiaofan Zhu, MD, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaofan Zhu, chief physician, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01990807
    Other Study ID Numbers:
    • CCALL2012
    First Posted:
    Nov 21, 2013
    Last Update Posted:
    Nov 21, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Xiaofan Zhu, chief physician, Chinese Academy of Medical Sciences
    high risk
    Philadelphia Chromosome absent
    Childhood acute lymphoblastic leukemia
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Philadelphia Chromosome
    Idarubicin

    Study Results

    No Results Posted as of Nov 21, 2013