Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 8:15 AM
Study NCT ID:
NCT06453460
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2024-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588473', 'term': 'letermovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant', 'timeFrame': '1 year after transplant', 'description': 'Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of CMV disease at 52 weeks after transplant', 'timeFrame': '1 year after transplant', 'description': 'Number of patients who develop CMV disease within 52 weeks after receiving a transplant'}, {'measure': 'Cumulative incidence of CMV related death at 52 weeks', 'timeFrame': '1 year after transplant', 'description': 'Number of patients who die from complications directly attributable to CMV infection within 52 weeks'}, {'measure': 'Overall Survival at 1 year after transplant', 'timeFrame': '1 year after transplant', 'description': 'Number of patients who survive beyond 1 year after transplant'}, {'measure': 'Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection', 'timeFrame': '1 year after transplant', 'description': 'Positive predictive value of CMV-TCIP assay at 14 weeks after transplant in predicting CS-CMVi protection through 1 year after transplant in patients who had letermovir discontinuation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CMV T Cell Immunity Panel', 'CMV reactivation', 'Allogeneic stem cell transplantation', 'Letermovir'], 'conditions': ['CMV', 'Allogeneic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years of age on the day of signing informed consent.\n* Karnofsky performance \\>70%\n* Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.\n* Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.\n* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.\n* Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.\n* Be able to comply with medical recommendations or follow-up.\n* Has adequate organ functions determined by\n\n 1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).\n 2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.\n 3. ALT or AST ≤200 IU/ml for adults.\n 4. Conjugated (direct) bilirubin \\< 2x upper limit of normal.\n 5. Left ventricular ejection fraction ≥40%.\n 6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.\n\nExclusion Criteria:\n\n* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.\n* Received within 7 days prior to screening or plans to receive during the study any of the following:\n\n 1. Ganciclovir\n 2. Valganciclovir\n 3. Foscarnet\n 4. Acyclovir (\\> 3200 mg PO per day or \\> 25 mg/kg IV per day)\n 5. Valacyclovir (\\> 3000 mg/day)\n 6. Famciclovir (\\> 1500 mg/day)\n* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.\n* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.\n* Has an uncontrolled infection\n* Requires mechanical ventilation or is hemodynamically unstable"}, 'identificationModule': {'nctId': 'NCT06453460', 'briefTitle': 'CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': '4005'}, 'secondaryIdInfos': [{'id': 'UCI 22-188', 'type': 'OTHER', 'domain': 'UCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AHCT recipients', 'interventionNames': ['Drug: Letermovir', 'Device: CMV T Cell Immunity Panel (CMV-TCIP)', 'Diagnostic Test: CMV DNA PCR']}], 'interventions': [{'name': 'Letermovir', 'type': 'DRUG', 'description': 'Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.', 'armGroupLabels': ['AHCT recipients']}, {'name': 'CMV T Cell Immunity Panel (CMV-TCIP)', 'type': 'DEVICE', 'description': "Viracor CMV-TCIP assay to measure how a person's immune system responds to CMV. Viracor CMV-TCIP will be measured monthly, starting at week 14, until positive, then at week 30 and 52.", 'armGroupLabels': ['AHCT recipients']}, {'name': 'CMV DNA PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Plasma level of CMV DNA PCR will be measured at enrollment and at least weekly through week 30, then at least every 2 weeks through week 52 of transplant if no GVHD or CMV reactivation.', 'armGroupLabels': ['AHCT recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Piyanuch Kongtim, MD, PhD', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}], 'facility': 'Chao Family Comprehensive Cancer Center, University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '1-877-827-8839'}, {'name': 'University of California Irvine Medical', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Piyanuch Kongtim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurofins Viracor', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Piyanuch Kongtim', 'investigatorAffiliation': 'University of California, Irvine'}}}}