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NCT03568266Recruiting

Pharmacogenomics of Asparaginase Induced Hepatotoxicity

University of Southern California

Start Date

5/22/2018

Completion Date

12/31/2027

Summary

This pilot trial studies the impact of genetic information on developing liver damage caused by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing saliva samples may help doctors find certain genetic markers that may predict whether participants will tolerate asparaginase, which is given as part of clinical care for acute lymphoblastic leukemia.

Detailed Description

PRIMARY OBJECTIVES: I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients. II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity. OUTLINE: Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified. Participants with the CC genotype will be compared to participants with the CT or TT genotype. Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). Retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during their regular clinical visits and samples will be collected.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL * Receiving asparaginase as part of the primary treatment regimen * Ability to understand and the willingness to sign a written informed consent * For retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of University of Southern California (USC) Exclusion Criteria: * Patients who are unable to give informed consent

Interventions

PROCEDURE

Biospecimen Collection

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Conditions

Acute Lymphoblastic Leukemia

Locations

Los Angeles General Medical Center

Los Angeles, California 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States