[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550928":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":45,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AHCT recipients","EXPERIMENTAL",null,[13,14,15],"Drug: Letermovir","Device: CMV T Cell Immunity Panel (CMV-TCIP)","Diagnostic Test: CMV DNA PCR",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Letermovir","Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DEVICE","CMV T Cell Immunity Panel (CMV-TCIP)","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.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DIAGNOSTIC_TEST","CMV DNA PCR","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.",[9],[33],{"name":34,"affiliation":35,"role":36},"Piyanuch Kongtim, MD,PhD","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","1-877-827-8839","ucstudy@uci.edu",{"name":44,"role":40,"phone":11,"phoneExt":11,"email":11},"University of California Irvine Medical",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Chao Family Comprehensive Cancer Center, University of California Irvine","RECRUITING","Orange","California","92868","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-117.85311,33.78779,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":11,"email":42},"Piyanuch Kongtim, MD, PhD","877-827-8839",{"type":36,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Piyanuch Kongtim","Associate Clinical Professor",[68],{"name":69,"class":70},"Eurofins Viracor","UNKNOWN","100550928","phase-2-cmv-tcip-directed-letermovir-prophylaxis-after-allo-sct-100550928",false,"NCT06453460","CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT","Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation","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\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin ≤1.5 mg\u002Fdl except for Gilbert's disease.\n  3. ALT or AST ≤200 IU\u002Fml for adults.\n  4. Conjugated (direct) bilirubin \\\u003C 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\u002Fkg IV per day)\n  5. Valacyclovir (\\> 3000 mg\u002Fday)\n  6. Famciclovir (\\> 1500 mg\u002Fday)\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\u002Fbiologic 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","ALL","18 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","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.",[88,89],"CMV","Allogeneic Stem Cell Transplantation",[91,92,93,19],"CMV T Cell Immunity Panel","CMV reactivation","Allogeneic stem cell transplantation","2025-07-03",{"date":96,"type":97},"2025-07-09","ACTUAL",{"date":99,"type":97},"2024-06-27",{"date":101,"type":82},"2029-06",{"name":5,"class":6},1]