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A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase

A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase

Recruiting
1 years and older
All
Phase N/A
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Overview

This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.

Description

PRIMARY OBJECTIVE:

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.

Eligibility

Inclusion Criteria:

  • Followed by pediatric hematology/oncology
  • Receiving recombinant Erwinia asparaginase for treatment of malignancy

Exclusion Criteria:

  • Patients < 1 year of age
  • Patients who have previously received recombinant Erwinia asparaginase within the past two weeks

Study details
    Hematopoietic and Lymphatic System Neoplasm
    Acute Lymphobkastic Leukemia

NCT06600659

Mayo Clinic

15 October 2025

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