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Completed

NCT Number: NCT01556386

Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia

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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of acute lymphoblastic leukemia
  • In case of informed consent and assent

Exclusion criteria

  • Paients or parents refusal

Treatment and study plan

Primary outcomes

  1. To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy

    Time frame: 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 outcomes

  1. To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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