Recruiting

Recombinant Erwinia Asparaginase

Sponsor:

Mayo Clinic

Code:

NCT06600659

Conditions

Hematopoietic and Lymphatic System Neoplasm

Acute Lymphobkastic Leukemia

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Conditions

Hematopoietic and Lymphatic System Neoplasm

Acute Lymphobkastic Leukemia

Study ID

NCT06600659

Start date

Nov 2, 2023

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Catherine E. Martin, PharmD, RPh

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-06.