- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990807
Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia
November 20, 2013 updated by: Xiaofan Zhu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
- 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
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaofan Zhu, MD
- Phone Number: +86-22-23909001
- Email: xfzhu1981@126.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300020
- Recruiting
- Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Scienses
-
Contact:
- Xiaofan Zhu, MD
- Phone Number: +86-22-23909001
- Email: xfzhu1981@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Children with high-risk ALL Children lower than 18years old
Exclusion Criteria:
Bcr/Abl(+) Children with middle-risk or standard-risk ALL
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The event free survival of high risk ALL
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The relapsed rate, death, overall survival
Time Frame: 2 years
|
2 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
infection rate
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
November 16, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 21, 2013
Study Record Updates
Last Update Posted (Estimate)
November 21, 2013
Last Update Submitted That Met QC Criteria
November 20, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Chromosome Aberrations
- Translocation, Genetic
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Philadelphia Chromosome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Idarubicin
Other Study ID Numbers
- CCALL2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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