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Observational Study of High Ammonia Levels with Recombinant Erwinia Asparaginase

This study is looking at how many patients develop high ammonia levels (hyperammonemia) after receiving a medicine called recombinant Erwinia asparaginase. This medicine is used to treat certain blood and lymphatic system cancers, like Acute Lymphoblastic Leukemia. The study will observe patients who are already receiving this treatment and are followed by a pediatric hematology/oncology team. You cannot join if you are under 1 year old or have received this medicine in the last two weeks. The main goal is to see how often high ammonia levels occur within 12 months of starting the treatment. This study aims to better understand this side effect and identify who might be at risk.

Study design
This is an observational study involving about 10 participants. It is not testing a new treatment but rather observing patients already receiving care.
What's involved
You would have blood samples collected, complete surveys, and your medical records would be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be observed for the incidence of hyperammonemia for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06600659

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

Recruiting
Not specifiedAges 1+Observational
Mayo Clinic
~10 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of patients who develop hyperammonemia
Measured over Up to 12 months

Conditions

Hematopoietic and Lymphatic System Neoplasm
Acute Lymphobkastic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaHematologic Neoplasm

NCT06600659

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Catherine E. Martin, PharmD, RPh · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

Followed by pediatric hematology/oncology
Receiving recombinant Erwinia asparaginase for treatment of malignancy

Exclusion

Patients \< 1 year of age
Patients who have previously received recombinant Erwinia asparaginase within the past two weeks

What this trial measures

  • Incidence of patients who develop hyperammonemiaUp 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.