Pharmacogenomics of Asparaginase Induced Hepatotoxicity

University of Southern California

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03568266

P30CA014089 (U.S. NIH Grant/Contract)

9L-17-16 (Other Identifier)

NCI-2018-00813 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Biospecimen Collection

Description:

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

Treatment:

Procedure: Biospecimen Collection