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Trial record 67 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Xiaofan Zhu, Chinese Academy of Medical Sciences

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
Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome, Ph^1^, Absent B-cell Childhood Acute Lymphoblastic Leukemia Drug: Idarubicin(IDA) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

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 Name: darubicin, IDA, Demethoxydaunor Ubicin

Primary Outcome Measures :
  1. The event free survival of high risk ALL [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The relapsed rate, death, overall survival [ Time Frame: 2 years ]

Other Outcome Measures:
  1. infection rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01990807

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Contact: Xiaofan Zhu, MD +86-22-23909001

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China, Tianjin
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   
Principal Investigator: Xiaofan Zhu, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Principal Investigator: Xiaofan Zhu, MD Chinese Academy of Medical Sciences

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Responsible Party: Xiaofan Zhu, chief physician, Chinese Academy of Medical Sciences Identifier: NCT01990807     History of Changes
Other Study ID Numbers: CCALL2012
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Keywords provided by Xiaofan Zhu, Chinese Academy of Medical Sciences:
high risk
Philadelphia Chromosome absent
Childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action