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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06600659

Enrollment

Registered

2024-09-19

Start date

2023-11-02

Completion date

2026-12-01

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphobkastic Leukemia, Hematopoietic and Lymphatic System Neoplasm

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTClinical Trials Referral Office

mayocliniccancerstudies@mayo.edu855-776-0015

PRINCIPAL_INVESTIGATORCatherine E. Martin, PharmD, RPh

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026