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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how many patients develop high ammonia levels that cause symptoms after getting a drug called recombinant Erwinia asparaginase. It is for patients getting this drug to treat cancer who are cared for by a children's blood and cancer care team.

This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Cared for by a children's blood and cancer care team.
  • Getting recombinant Erwinia asparaginase to treat cancer.

Who can't join

  • Younger than 1 year old.
  • Received recombinant Erwinia asparaginase within the past two weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MN