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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01023 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-006011 | Other Identifier | Mayo Clinic in Rochester |
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This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving recombinant Erwinia asparaginase for treatment of malignancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Catherine E. Martin, PharmD, RPh | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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