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Pharmacogenomics of Asparaginase Induced Hepatotoxicity

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ClinicalTrials.gov Identifier: NCT03568266
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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 Intervention/treatment
Acute Lymphoblastic Leukemia Procedure: 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : May 22, 2024
Estimated Study Completion Date : May 22, 2025


Group/Cohort Intervention/treatment
Biospecimen Collection
Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit) from their asparaginase treatment.
Procedure: Biospecimen Collection
Undergo collection of saliva




Primary Outcome Measures :
  1. Hepatotoxicity following treatment with asparaginase [ Time Frame: Up to 6 months ]
    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.


Biospecimen Retention:   Samples With DNA
Saliva


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed with Acute Lymphoblastic Leukemia (ALL) who are seen at USC facilities will be recruited.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568266


Contacts
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Contact: Christine Duran 323-865-0371 Duran_C@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Houda Alachkar, PhD    323-442-2696    alachkar@usc.edu   
Principal Investigator: Houda Alachkar, PhD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Houda Alachkar, Ph.D. University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03568266     History of Changes
Other Study ID Numbers: 9L-17-16
NCI-2018-00813 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9L-17-16 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents