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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Southern California Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | May 22, 2018 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT03568266 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.
-
Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia
This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.
-
Observatory of adults with Ph+ ALL receiving BCR-ABL1 inhibitors with chemotherapy, steroids, or monoclonal antibodies
This study follows adults with Philadelphia-positive acute lymphoblastic leukemia who are being treated with a combination of BCR-ABL1 inhibitors and other therapies to see how they fare in real-world practice.
-
Strength Training for Kids with Acute Lymphoblastic Leukemia and Lymphoblastic L lymphoma
Researchers are testing a structured strength-training program for children and teens recently diagnosed with ALL or lymphoblastic lymphoma to see if it helps with weight gain and physical function during treatment.
-
FXS0683 in relapsed or refractory blood cancers
This first‑in‑human study tests FXS0683 in adults with relapsed or refractory B‑cell lymphoma, AML, MDS, or ALL to see if it is safe, how the drug behaves in the body, and whether it shows any antitumor activity.
-
CD19-targeted CAR-T cells that make p40 for relapsed or refractory CD19-positive blood cancers
This trial will try a patient's own CD19-directed CAR-T cells engineered to produce p40 to see if they work better and last longer in adults with relapsed or refractory CD19-positive blood cancers.
-
TSLPR-CART therapy for CRLF2-R/TSLPR–expressing B-ALL in adults
This study tests a CAR T-cell treatment called TSLPR-CART in adults whose B-ALL cells overexpress TSLPR and have not responded to standard therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.