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Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01556386
Collaborator
(none)
200
Enrollment
1
Location
71
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cure rate of pediatric ALL dramatically improved over 80%. Resistance to drug and hematologic relapse are remaining problem in ALL treatment. One of the explanations of drug resistance and toxicities is the pharmacogenetic effect. Germline polymorphisms in genes that code for proteins involved in the pharmacokinetics and pharmacodynamics of antileukemic agents are various, and inter-patient variability is the main factor for pharmacogenetic difference. Since multiple chemotherapeutic agents are involved in treating ALL, many genes related to the metabolic pathways of those drugs have an effect on the pharmacokinetics of patients with ALL. In Korea, pharmacogenetic study including multiple genetic loci for pediatric ALL has not been reported.In this study, the distribution of genetic polymorphisms and genes related to antileukemic drugs were analyzed, and their relations to the outcome of treatment and relapse rates were assessed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Time Perspective:
    Retrospective
    Official Title:
    Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    May 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Pharmacogenetic analysis, ALL

    Outcome Measures

    Primary Outcome Measures

    1. To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy [up to 3 years from diagnosis]

      The distribution of each genetic polymorphism is descriped. The differences in genetic polymorphism between risk groups (high vs. standard) are analyzed using the chi-square test or Fisher's exact test.

    Secondary Outcome Measures

    1. To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL [whenever after diagnosis and genetic analysis (no time frame needed)]

      • The differences in genetic polymorphism between other populations (Korean vs. Western or Japanese) are analyzed using the chi-square test or Fisher's exact test.

    2. To find out relation of genetic polymorphisms and clinical outcome (relapse or survival) [up to 3 years from diagnosis]

      - Event-free and overall survival are estimated using Kaplan-Meier analysis, and the survival differences according to different genetic polymorphisms and prognostic variables are analyzed by log-rank test.

    3. To find out risk factors of relapse and death [up to 3 years from diagnosis]

      - Multivariate analysis is conducted with Cox proportional hazards regression model to analyze predictive factors. For the multivariate analysis, all significant univariate variables are entered in a stepwise, forward-selection protocol.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of acute lymphoblastic leukemia

    • In case of informed consent and assent

    Exclusion Criteria:
    • Paients or parents refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Chongno-gu Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hyoung Jin Kang, MD. PhD., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyo Seop Ahn, MD. Ph D., Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01556386
    Other Study ID Numbers:
    • SNUCH-1202
    First Posted:
    Mar 16, 2012
    Last Update Posted:
    Jul 14, 2014
    Last Verified:
    Dec 1, 2013
    Keywords provided by Hyo Seop Ahn, MD. Ph D., Professor, Seoul National University Hospital
    acute lymphoblastic leukemia
    single nucleotide polymorphism
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Jul 14, 2014