Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:40 AM
Study NCT ID:
NCT07424157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Leftover samples of your blood, bone marrow, spinal fluid or other tissue obtained as part of the LTFU study will be retained as part of the SCTx Biobank for use in future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2041-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2041-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delayed adverse events', 'timeFrame': '15 years post-final infusion of SCTx GTP', 'description': 'The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.'}, {'measure': 'Long-term persistence of SCTx Gene Therapy Products', 'timeFrame': '15 years post-final infusion', 'description': 'Monitor for long-term persistence of SCTx GTPs.'}, {'measure': 'Long-term clinical outcomes following treatment with SCTx GTP', 'timeFrame': '15 years post-final infusion', 'description': 'Death from any cause and first relapse following an initial remission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CAR T Cell', 'CAR T Cell Therapy']}, 'descriptionModule': {'briefSummary': "Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have received treatment with a gene therapy product on an SCTx Sponsored clinical trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Enrolled in an SCTx GTP clinical trial;\n2. Received or planned to receive an SCTx GTP;\n3. Subject and/or legally authorized representative have provided consent/assent for study participation.'}, 'identificationModule': {'nctId': 'NCT07424157', 'acronym': 'LTFU-01', 'briefTitle': "Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products", 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': "Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products", 'orgStudyIdInfo': {'id': 'LTFU-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Long term follow up in all patients who received an SCTx gene therapy product', 'type': 'OTHER', 'description': 'Participants will be followed for 15 years following the receipt of their final infusion on a separate SCTx gene therapy protocol to monitor for the long term effects of CAR T cell therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'contacts': [{'name': 'Adam Lamble', 'role': 'CONTACT', 'email': 'CBDCIntake@seattlechildrens.org', 'phone': '206-987-2106'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Adam Lamble', 'role': 'CONTACT', 'email': 'CBDCIntake@seattlechildrens.org', 'phone': '206-987-2106'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SCTx Medical Director', 'investigatorFullName': 'Colleen Annesley', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}