Pharmacogenomics of Asparaginase Induced Hepatotoxicity
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
3 other identifiers
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2018
CompletedFirst Submitted
Initial submission to the registry
June 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 4, 2025
December 1, 2025
8.1 years
June 14, 2018
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Biospecimen Collection
Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.
Interventions
Eligibility Criteria
Newly diagnosed with Acute Lymphoblastic Leukemia (ALL) who are seen at USC facilities will be recruited.
You may qualify if:
- 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)
You may not qualify if:
- Patients who are unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Houda Alachkar, Ph.D.
University of Southern California
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2018
First Posted
June 26, 2018
Study Start
May 22, 2018
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 4, 2025
Record last verified: 2025-12