A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
Mayo Clinic
Summary
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
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
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
- OtherNon-Interventional Study
Non-interventional study
Location
- Mayo Clinic in RochesterRochester, Minnesota