Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-26 @ 6:00 PM
Study NCT ID:
NCT06441669
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588473', 'term': 'letermovir'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of immune cells in peripheral blood', 'timeFrame': 'one year', 'description': 'PBMCs from UCBT recipients were collected at 1 month, 2 month, 3 month, and 6 month and 12 month after HSCT, and tested for CMV-specific T cells, NK cells, T cells and other subsets.'}, {'measure': 'CMV DNAemia', 'timeFrame': 'one year', 'description': 'CMV DNAemia is defined as the detection of CMV DNA in samples of plasma, whole blood or isolated peripheral blood leukocyte.'}, {'measure': 'Incidence of refractory CMV infection', 'timeFrame': 'one year', 'description': 'Refractory CMV infection is defined as CMV viral load remaining at the same level or increasing despite appropriately doses of antiviral therapy for at least 2 weeks'}, {'measure': 'late CMV reactivation', 'timeFrame': 'one year', 'description': 'Late CMV reactivation is defined as reactivation that occurs 100 days post UCBT, which means reactivation after discontinuing LET prophylaxis.'}], 'secondaryOutcomes': [{'measure': 'Treatment-ralated mortality', 'timeFrame': 'one year', 'description': 'Treatment-ralated mortality'}, {'measure': 'Incidence of other viral infection and viral-associated disease', 'timeFrame': 'one year', 'description': 'Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV'}, {'measure': 'Overall survival', 'timeFrame': 'one year', 'description': 'Overall survival'}, {'measure': 'serum immunoglobulin assay', 'timeFrame': '1,3,6,9 month post UCBT', 'description': 'The serum levels of IgG, IgM, and IgA were measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cytomegalovirus Infection', 'Umbilical Cord Blood Transplantation', 'CMV-Specific Immune Reconstitution', 'Letermovir'], 'conditions': ['Cytomegalovirus Infection Reactivation']}, 'descriptionModule': {'briefSummary': 'To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation', 'detailedDescription': 'To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study consists 60 cases recipients of UCBT. All patients will receive letermovir prophylaxis within 0-28 days post UCBT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are receiving a first unrelated cord blood transplantation (UCBT).\n* Patients start letemovir prophylaxis within 0-28 days post UCBT.\n\nExclusion Criteria:\n\n* Patients having active CMV DNAemia at the time of letermovir initiation.\n* Patients recruited in a clinical study on an anti-CMV trial.'}, 'identificationModule': {'nctId': 'NCT06441669', 'briefTitle': 'Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'Effect of Letermovir Prophylaxis on Cytomegalovirus-specific Immune Reconstitution Post Unrelated Cord Blood Transplantation', 'orgStudyIdInfo': {'id': 'CBCMV001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'letermovir group', 'description': 'Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT.', 'interventionNames': ['Drug: Letermovir']}], 'interventions': [{'name': 'Letermovir', 'type': 'DRUG', 'description': 'Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.', 'armGroupLabels': ['letermovir group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyu Zhu, ph.D', 'role': 'CONTACT', 'email': 'xiaoyuz@ustc.edu.cn', 'phone': '15255456091'}, {'name': 'Bingbing Yan', 'role': 'CONTACT', 'email': 'bing0415@mail.ustc.edu.cn', 'phone': '15993691727'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Xiaoyu Zhu, ph.D', 'role': 'CONTACT', 'email': 'xiaoyuz@ustc.edu.cn', 'phone': '15255456091'}, {'name': 'Bingbing Yan', 'role': 'CONTACT', 'email': 'bing0415@mail.ustc.edu.cn', 'phone': '15993691727'}], 'overallOfficials': [{'name': 'Xiaoyu Zhu, ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}