Actively Recruiting
A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
Led by Mayo Clinic · Updated on 2026-02-06
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine how often patients develop symptomatic hyperammonemia, which means high ammonia levels, when treated with recombinant Erwinia asparaginase. It also seeks to identify which patients are more at risk for this condition. The study focuses on patients with hematopoietic and lymphatic system neoplasms, including acute lymphoblastic leukemia. This is an observational study where patients receive their usual care while researchers collect information. Participants undergo blood sample collection, complete surveys, and have their medical records reviewed to gather data related to their treatment with recombinant Erwinia asparaginase. Participants will be monitored for up to 12 months to track the incidence of hyperammonemia. Throughout the study, researchers will review blood test results, questionnaires, and medical records to understand patient risk factors and outcomes. No treatment is altered for study purposes, and data collection supports understanding the condition's development during therapy.
CONDITIONS
Brief Title
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Followed by pediatric hematology/oncology
- Receiving recombinant Erwinia asparaginase for treatment of malignancy
- Age 1 year or older
You will not qualify if you...
- Patients younger than 1 year of age
- Patients who have received recombinant Erwinia asparaginase within the past two weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo blood sample collection, complete surveys, and have their medical records reviewed to monitor for hyperammonemia.
Visits occur as part of routine clinical care and study assessments
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here