Observational Study of Asparaginase and Liver Damage

This study is looking at how your genes might affect whether you develop liver damage (hepatotoxicity) when treated with asparaginase for acute lymphoblastic leukemia (ALL). Researchers will collect a saliva sample from you to look for specific genetic markers. The goal is to see if these markers can help doctors predict who might have liver problems with asparaginase. This could help doctors better manage treatment for people with ALL. You may be able to join if you are newly diagnosed with ALL and receiving asparaginase, or if you received asparaginase between 2012 and 2017 and are a current patient at the University of Southern...

Study design
This is an observational study planning to enroll 500 participants. It is not a treatment study but rather looks at existing medical information and collected samples.
What's involved
You would provide a saliva sample, typically during a regular clinical visit. For those already treated, samples will be collected during a regular clinical visit after consent.
Compensation
Not stated in the trial record.
Follow-up
Liver damage will be measured for up to 6 months after treatment with asparaginase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03568266

Pharmacogenomics of Asparaginase Induced Hepatotoxicity

Recruiting
Not specifiedAges 18+Observational
University of Southern California
~500 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Biospecimen Collection

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatotoxicity following treatment with asparaginase
Measured over Up to 6 months
Acute Lymphoblastic Leukemia

NCT03568266

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Los Angeles General Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Houda Alachkar, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Southern California

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Eligibility criteria

Inclusion

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

Patients who are unable to give informed consent
  • Hepatotoxicity following treatment with asparaginaseUp 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.