Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT03568266

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Study Details

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Study ID

NCT03568266

Start date

May 22, 2018

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Biospecimen Collection

Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.

Interventions

Biospecimen Collection

Undergo collection of saliva

Primary outcome measure

  • Hepatotoxicity following treatment with asparaginase [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Christine Duran

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

Locations

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Houda Alachkar, PhD

323-442-2696alachkar@usc.edu

Principal Investigator:

Houda Alachkar, PhD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Houda Alachkar, PhD

323-442-2696alachkar@usc.edu

Principal Investigator:

Houda Alachkar, PhD

More Information

Sponsor

University of Southern California

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-01.