Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-04 @ 2:04 PM
Study NCT ID:
NCT07221656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-10-24', 'studyFirstSubmitQcDate': '2025-10-24', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Asparaginase-related toxicities correlated with duration of therapeutic SAA levels', 'timeFrame': 'Up to 15 months', 'description': 'Spline plots will be used to assess any correlation between duration of therapeutic SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.'}, {'measure': 'Asparaginase-related toxicities correlated with peak SAA levels', 'timeFrame': 'Up to 15 months', 'description': 'Spline plots will be used to assess any correlation between peak SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.'}], 'primaryOutcomes': [{'measure': 'Duration of therapeutic SAA', 'timeFrame': 'Up to 15 months', 'description': 'Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Acute Lymphoblastic Leukemia', 'Childhood Lymphoblastic Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the median duration of therapeutic serum asparaginase activity (SAA) levels after administration of calaspargase pegol (Cal-PEG) and the potential association between peak SAA levels and duration of therapeutic levels with toxicity in pediatric patients with acute lymphoblastic leukemia or lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team at Mayo Clinic in Rochester', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team\n* Receiving calaspargase as part of treatment for malignancy\n\nExclusion Criteria:\n\n* Age \\> 21 years\n* Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT07221656', 'briefTitle': 'Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration', 'orgStudyIdInfo': {'id': '25-009034'}, 'secondaryIdInfos': [{'id': 'NCI-2025-07667', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '25-009034', 'type': 'OTHER', 'domain': 'Mayo Clinic'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'otherNames': ['Non-Interventional Observational Study', 'Noninterventional (Observational) Study'], 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Pediatric Research', 'role': 'CONTACT', 'phone': '507-266-2942'}, {'name': "Madeleine B. O'Keefe, MD", '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': "Madeleine B. O'Keefe, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}