Genetic factors affecting liver damage from asparaginase in leukemia patients
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
This study is testing how certain genes might affect the risk of liver damage from asparaginase in people newly diagnosed with acute lymphoblastic leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03568266 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients with acute lymphoblastic leukemia who are receiving asparaginase as part of their treatment.
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.
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 performed: Other studies have explored genetic factors in drug-induced toxicity, suggesting potential for success in this area, though this specific approach may be novel.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.