Pharmacogenomics of Asparaginase Induced Hepatotoxicity

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Procedure: Biospecimen Collection

• Registration Number: NCT03568266
• Lead Sponsor: University of Southern California

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-05-22
• Study Completion: 2026-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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)

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Exclusion Criteria

• Patients who are unable to give informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biospecimen Collection	Biospecimen Collection	Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.

Primary Outcome Measures

Name	Time	Method
Hepatotoxicity following treatment with asparaginase	Up to 6 months	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States