Pharmacogenomics of Asparaginase Induced Hepatotoxicity

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT03568266
Collaborator
National Cancer Institute (NCI) (NIH)
500
1
84
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:
  1. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.

  2. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Actual Study Start Date :
May 22, 2018
Anticipated Primary Completion Date :
May 22, 2024
Anticipated Study Completion Date :
May 22, 2025

Arms and Interventions

Arm Intervention/Treatment
Biospecimen Collection

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
Undergo collection of saliva

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Houda Alachkar, Ph.D., University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT03568266
Other Study ID Numbers:
  • 9L-17-16
  • NCI-2018-00813
  • 9L-17-16
  • P30CA014089
First Posted:
Jun 26, 2018
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021