Evaluating high ammonia levels in patients treated with Erwinia asparaginase
A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06600659 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients receiving recombinant Erwinia asparaginase for malignancy under the care of a hematology/oncology specialist.
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.
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 performed: While this study focuses on a specific adverse effect, similar observational studies have successfully identified risks associated with cancer treatments.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.