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

Recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Acute Lymphobkastic Leukemia
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06600659
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2023-11-02
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Incidence of patients who develop hyperammonemia	Up to 12 months	Assessed by measuring ammonia levels via blood test. Baseline ammonia level will be determined around the time of consent. During the first two recombinant Erwinia asparaginase (Rylaze®) courses, there will be two blood draws per week. Each course of recombinant Erwinia asparaginase (Rylaze®) lasts for two weeks, so there will be four blood draws per course.

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States