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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
- ClinicalTrials.gov ID
- NCT06600659
- Acronym / sponsor ID
- 23-006011
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood sample collection, complete surveys, and have their medical records reviewed on study. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving recombinant Erwinia asparaginase for treatment of malignancy
Key inclusion criteria (2 listed)
- Followed by pediatric hematology/oncology
- Receiving recombinant Erwinia asparaginase for treatment of malignancy
Key exclusion criteria (2 listed)
- Patients < 1 year of age
- Patients who have previously received recombinant Erwinia asparaginase within the past two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Incidence of patients who develop hyperammonemia
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine E. Martin, PharmD, RPh principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Acute Lymphobkastic Leukemia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients who develop hyperammonemia (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.