Hematopoietic and Lymphatic System NeoplasmNCT06600659
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
An observational study of Hematopoietic and Lymphatic System Neoplasm and Acute Lymphobkastic Leukemia, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Acute Lymphobkastic Leukemia
- What is being tested?
- Non-Interventional Study
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving recombinant Erwinia asparaginase for treatment of malignancy
Who may be able to join
- Followed by pediatric hematology/oncology
- Receiving recombinant Erwinia asparaginase for treatment of malignancy
Who cannot join
- Patients < 1 year of age
- Patients who have previously received recombinant Erwinia asparaginase within the past two weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Alexis Kuhn, PharmD, RPh
About this study
Official title: A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients who develop hyperammonemia
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine E. Martin, PharmD, RPh, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600659
- Sponsor's protocol ID
- 23-006011
- Other IDs
- NCI-2024-01023, 23-006011
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No