A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
NCT ID: NCT06600659
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2023-11-02
2026-12-01
Brief Summary
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Detailed Description
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I. To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase.
II. To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase.
OUTLINE: This is an observational study.
Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Receiving recombinant Erwinia asparaginase for treatment of malignancy
Exclusion Criteria
* Patients who have previously received recombinant Erwinia asparaginase within the past two weeks
1 Year
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Catherine E. Martin, PharmD, RPh
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Alexis Kuhn, PharmD, RPh
Role: backup
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-01023
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-006011
Identifier Type: OTHER
Identifier Source: secondary_id
23-006011
Identifier Type: -
Identifier Source: org_study_id
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