Evaluating high ammonia levels in patients treated with Erwinia asparaginase
Official title: A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
Run by Mayo Clinic · NCT06600659 · Data updated 2026-11-12
This study is testing how many patients with acute lymphoblastic leukemia treated with Erwinia asparaginase develop high ammonia levels and who might be at risk for this problem.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | November 2, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT06600659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients receiving recombinant Erwinia asparaginase for malignancy under the care of a hematology/oncology specialist.
✕Probably not a fit
Patients under 1 year of age or those who have received recombinant Erwinia asparaginase within the past two weeks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the incidence of symptomatic hyperammonemia in patients undergoing treatment with recombinant Erwinia asparaginase for hematopoietic and lymphatic system neoplasms, particularly acute lymphoblastic leukemia. The primary objectives include determining how many patients develop high ammonia levels and identifying those at risk for this condition. Participants will provide blood samples, complete surveys, and have their medical records reviewed to gather comprehensive data on the effects of the treatment.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for hyperammonemia, leading to better management and treatment strategies.
How similar studies have gone: While this study focuses on a specific adverse effect, similar observational studies have successfully identified risks associated with cancer treatments.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Catherine E. Martin, PharmD, RPh — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.