Clinical trial · Observational
Pharmacogenomics of Asparaginase Induced Hepatotoxicity
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
NCT03568266CI-TRIAL-00113210recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biospecimen Collection
- description
- Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Hepatotoxicity following treatment with asparaginase
- timeFrame
- Up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.