Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT06600659
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of patients who develop hyperammonemia', 'timeFrame': 'Up to 12 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphatic System Neoplasm', 'Acute Lymphobkastic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase.\n\nII. To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving recombinant Erwinia asparaginase for treatment of malignancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Followed by pediatric hematology/oncology\n* Receiving recombinant Erwinia asparaginase for treatment of malignancy\n\nExclusion Criteria:\n\n* Patients \\< 1 year of age\n* Patients who have previously received recombinant Erwinia asparaginase within the past two weeks'}, 'identificationModule': {'nctId': 'NCT06600659', 'briefTitle': 'A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase', 'orgStudyIdInfo': {'id': '23-006011'}, 'secondaryIdInfos': [{'id': 'NCI-2024-01023', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '23-006011', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Alexis Kuhn, PharmD, RPh', 'role': 'CONTACT'}, {'name': 'Catherine E. Martin, PharmD, RPh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Catherine E. Martin, PharmD, RPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}