Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Genetic factors affecting liver damage from asparaginase in leukemia patients

Official title: Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia

Run by University of Southern California · NCT03568266 · Data updated 2026-11-12

This study is testing how certain genes might affect the risk of liver damage from asparaginase in people newly diagnosed with acute lymphoblastic leukemia.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorUniversity of Southern California
Academic / other
Locations2 sites (Los Angeles, California and 1 other locations)
StatusRecruiting
StartedMay 22, 2018
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedJune 1, 2026
Trial IDNCT03568266 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are newly diagnosed patients with acute lymphoblastic leukemia who are receiving asparaginase as part of their treatment.

Probably not a fit

Patients who are unable to provide informed consent or have prior treatment for acute lymphoblastic leukemia will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates how genetic information may influence the risk of liver damage caused by asparaginase in patients newly diagnosed with acute lymphoblastic leukemia. The study focuses on the SOD2 rs4880 genotype and aims to identify novel single nucleotide polymorphisms (SNPs) associated with hepatotoxicity. Participants will provide saliva samples for genetic testing, which will help determine their tolerance to asparaginase treatment. The study includes both prospective and retrospective participants, with data collected during regular clinical visits.

Why it matters

Potential benefit: If successful, this study could help identify patients at risk for liver damage from asparaginase, allowing for personalized treatment plans.

How similar studies have gone: Other studies have explored genetic factors in drug-induced toxicity, suggesting potential for success in this area, though this specific approach may be novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Los Angeles General Medical Center
    Los Angeles, California, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting

Study contacts

  • Principal investigator: Houda Alachkar, Ph.D. — University of Southern California
  • Study coordinator: Christine Duran
  • Email: Duran_C@med.usc.edu
  • Phone: 323-865-0371

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.