NCT06600659

A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase

A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Acute Lymphobkastic Leukemia

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-09-19
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study