RecruitingNot Applicable

Pharmacogenomics of Asparaginase Induced Hepatotoxicity

United States500 participantsStarted 2018-05-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hepatotoxicity following treatment with asparaginase

Timeframe: Up to 6 months

Trial details

NCT IDNCT03568266

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Christine Duran

323-865-0371 Duran_C@med.usc.edu

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials