Pharmacogenomics of Asparaginase Induced Hepatotoxicity
ConditionAcute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients who are unable to give informed consent
Trial population
Newly diagnosed with Acute Lymphoblastic Leukemia (ALL) who are seen at USC facilities will be recruited.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of saliva
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Biospecimen Collection1 intervention
Trial outcomes
Primary outcomes
1
Hepatotoxicity following treatment with asparaginase
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.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov