Pharmacogenomics of Asparaginase Induced Hepatotoxicity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Procedure: Biospecimen Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biospecimen Collection<br>Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment. | Procedure: Biospecimen Collection<br>* Undergo collection of saliva<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatotoxicity following treatment with asparaginase | Hepatotoxicity per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and defined as > or = grade 3 of both aspartate aminotransferase (AST) and alanine aminotransferase (ALT), or > or = grade 3 bilirubin elevation. | Up to 6 months |