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NCT03568266 | RECRUITING | Acute Lymphoblastic Leukemia

Pharmacogenomics of Asparaginase Induced Hepatotoxicity
Sponsor:

University of Southern California

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.

Condition or disease

Acute Lymphoblastic Leukemia

Intervention/treatment

Biospecimen Collection

Detailed Description:

PRIMARY OBJECTIVES: I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients. II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity. OUTLINE: Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified. Participants with the CC genotype will be compared to participants with the CT or TT genotype. Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). Retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during their regular clinical visits and samples will be collected.

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Actual Study Start Date : 2018-05-22
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Pharmacogenomics of Asparaginase Induced Hepatotoxicity

Location Details

NCT03568266

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033