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Recruiting NCT06600659

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

— Observational Hematopoietic and Lymphatic System Neoplasm Acute Lymphobkastic Leukemia

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Acute Lymphobkastic Leukemia. Basic parameters: from 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Incidence of patients who develop hyperammonemia [Time frame: Up to 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06600659 · 23-006011 · NCI-2024-01023 · 23-006011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗