Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556386
• Other study ID #: SNUCH-1202
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: July 11, 2014
• Start date: June 2006
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute lymphoblastic leukemia

• In case of informed consent and assent

Exclusion Criteria:

• Paients or parents refusal

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy	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.	up to 3 years from diagnosis	No
Secondary	To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL	• 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.	whenever after diagnosis and genetic analysis (no time frame needed)	No
Secondary	To find out relation of genetic polymorphisms and clinical outcome (relapse or survival)	- 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.	up to 3 years from diagnosis	No
Secondary	To find out risk factors of relapse and death	- 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.	up to 3 years from diagnosis	No