NCT06600659Recruiting
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
Mayo Clinic
Start Date
11/2/2023
Completion Date
12/1/2026
Summary
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
Detailed 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 Criteria
Age Range: 1 years to No maximum
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
Interventions
OTHER
Non-Interventional Study
Conditions
Hematopoietic and Lymphatic System NeoplasmAcute Lymphobkastic Leukemia
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States