[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482635":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":41,"overallOfficials":56,"centralContacts":60,"locations":68,"responsibleParty":134,"collaborators":16,"id":137,"slug":16,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":16,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":16,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":16,"overallStatus":71,"whyStopped":16,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"New York Medical College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"To determine the safety of giving CMV CTLs combined with anti-viral therapy in neonates with CMV","the incidence and severity of Grade I-IV acute GVHD within 8 weeks that is probably or directly related to CMV-CTL infusion after last CMV CTL infusion will be evaluated to determine the safety profile of CMV CTLs in neonates","12 weeks",{"measure":14,"description":15,"timeFrame":12},"To determine response rates to treatment with CMV CTLS and anti-viral medication","response rates will be measured by monitoring CMV PCR levels. A complete response to CMV-CTLs will be those with undetectable viral load by qRT-PCR",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","Given the vulnerability and poor outcomes of preterm neonates and neonates in general to viral infection, including the need for prolonged antiviral therapy for 6 or more months to achieve just modest improvements in sensorineural functions, CMV CTL therapy offers a promising alternative. CMV CTL treatment will build on the hosts innate immune capacity to create a more effective and permanent defense against collateral injury arising from CMV infections.\n\nPatients who meet all inclusion\u002Fexclusion criteria with a maternal donor who meet all donor criteria will be enrolled onto study.\n\nCohort 1 is a safety run-in; the first 3 patients enrolled will be treated with anti-viral and CMV CTLs. The external DSMB will review the data from the first patient, and if there are no adverse events or dose-limiting toxicities observed, approve patient 2, and then 3, 28 days after the prior patients last CTL infusion. Assuming there are no adverse events in any of the first 3 patients, the study will proceed to Cohort 2.\n\nCohort 2 will be randomized 1:1 to either anti-viral treatment alone or anti-viral treatment plus CMV CTLs.\n\nPatients who are randomized to receive CMV CTLs will get their first infusion on Day 0. If the patient fails to achieve a CR, they may receive one infusion every 2 weeks up to 5 maximum CMV CTL infusions as long as there are no DLTs or AEs observed",[25,32,36],{"label":26,"type":27,"description":28,"interventionNames":29},"Cohort 1 Safety Run-in","EXPERIMENTAL","The first 3 patients enrolled will receive both anti-viral medication and CMV CTLs, and treatment will be staggered every 28 days from the last dose of CMV CTLs from the prior patient.",[30,31],"Biological: CMV Cytotoxic T-Lymphocytes","Drug: Anti-viral Therapy",{"label":33,"type":27,"description":34,"interventionNames":35},"Cohort 2 Antiviral medication + CMV CTLs","Patients will receive both anti-viral medication and CMV CTLs",[30,31],{"label":37,"type":38,"description":39,"interventionNames":40},"Cohort 2 Antiviral medication only","ACTIVE_COMPARATOR","Patients will only receive anti-viral therapy",[31],[42,49],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BIOLOGICAL","CMV Cytotoxic T-Lymphocytes","Patients will receive maternal CMV CTLs on day 0. Additional doses of CMV CTLs may be re-infused at a minimum of every two weeks for a maximum of five total infusions (maximum 2.5 x 104 CD3\u002Fkg) only in patients not achieving a CR and no prior dose limiting toxicity of any prior dose.",[26,33],[48],"CTLs",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Anti-viral Therapy","All patients will receive anti-viral therapy with one of the following:\n\n4.2.2 Valganciclovir Dosing: 16 mg\u002Fkg\u002Fdose PO q12h OR 4.2.3 Ganciclovir Dosing: 6 mg\u002Fkg\u002Fdose IV q12h\n\nDose adjustments:\n\n* Reduce dose by 50% for ANC less than 500 cells\u002Fmm3\n* Hold the dose if ≤ 200 cells\u002Fmm3 until recovery ≥ 500 cells\u002Fmm3\n* Treatment will continue for 6 months",[26,33,37],[55],"valganciclovir, ganciclovir",[57],{"name":58,"affiliation":5,"role":59},"Mitchell Cairo, MD","PRINCIPAL_INVESTIGATOR",[61,65],{"name":58,"role":62,"phone":63,"phoneExt":16,"email":64},"CONTACT","914-594-2150","mitchell_cairo@nymc.edu",{"name":66,"role":62,"phone":16,"phoneExt":16,"email":67},"Edo Schaefer, MD","eshaefe@nymc.edu",[69,90,104,120],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-118.24368,34.05223,{"lat":81,"lon":80},[84,87],{"name":85,"role":62,"phone":16,"phoneExt":16,"email":86},"Neena Kapoor, MD","nkapoor@chla.usc.edu",{"name":88,"role":62,"phone":16,"phoneExt":16,"email":89},"Phillippe Friedlich, MD","pfriedlich@chla.usc.edu",{"facility":91,"status":71,"city":92,"state":93,"zip":94,"country":75,"countryCode":76,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Washington University","St Louis","Missouri","63130",{"type":78,"coordinates":96},[97,98],-90.19789,38.62727,{"lat":98,"lon":97},[101],{"name":102,"role":62,"phone":16,"phoneExt":16,"email":103},"Carol Kao, MD","kaoc@wustl.edu",{"facility":5,"status":71,"city":105,"state":106,"zip":107,"country":75,"countryCode":76,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Valhalla","New York","10595",{"type":78,"coordinates":109},[110,111],-73.77513,41.07482,{"lat":111,"lon":110},[114,116],{"name":58,"role":62,"phone":115,"phoneExt":16,"email":64},"914-594-3650",{"name":117,"role":62,"phone":118,"phoneExt":16,"email":119},"Lauren Harrison, MSN","617-285-7844","lauren_harrison@nymc.edu",{"facility":121,"status":71,"city":122,"state":123,"zip":124,"country":75,"countryCode":76,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Nationwide Children's Hosptial","Columbus","Ohio","43205",{"type":78,"coordinates":126},[127,128],-82.99879,39.96118,{"lat":128,"lon":127},[131],{"name":132,"role":62,"phone":16,"phoneExt":16,"email":133},"Masako Shimamura, MD","masako.shimamura@nationwidechildrens.org",{"type":59,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Mitchell Cairo","Principal Investigator","100482635",false,"NCT05564598","CMV CTLs in Neonates With CMV Infection","A Phase II Open-Label Randomized Study of Anti-Viral Antibiotic Therapy With and Without Familial (Maternal) Cytomegalovirus (CMV) Cytotoxic T Lymphocytes (CTLs) in Neonates With Moderate\u002FSevere Maternal Acquired CMV Infection","Inclusion Criteria:\n\n* Age: ≤ 21 days of life\n* Birth Weight: ≥ 2500 gms\n* Gestational age: ≥ 34 weeks of age\n* Diagnosis of CMV viremia, viruria, and\u002For infection:Either one or more:\n\nElevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and\u002For Positive urine culture for CMV\n\n\\- Moderate or Severe CMV Disease\n\nAny one or more of the following attributable to congenital CMV infection:\n\n* Thrombocytopenia (≤ 50,000 mm3)\n* Multiple petechiae\n* Hepatomegaly\n* Splenomegaly\n* Intrauterine growth retardation\n* Increased transaminases\n* Increased bilirubin\n* Microcephaly\n* Ventriculomegaly\n* Intracerebral calcifications\n* Periventricular echogenicity\n* Cortical or cerebral malformation\n* Chorioretinitis\n* Severe neonatal hearing loss\n* CMV DNA by PCR in CNS\n* Increased WBC for age in CNS\n\n  * Minimal Organ Criteria Hematological: ANC ≥ 750\u002Fmm3, HgB ≥ 8gm\u002Fdl, Platelets ≥ 20,000\u002Fkmm3 Renal: Serum creatinine ≤ 1.0 mg\u002Fdl Hepatic: ALT\u002FSGOT ≤3x upper normal limits\n  * Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is \\> 0.01% after stimulation with PepTivators.\n\nExclusion Criteria -\n\n* Patient receiving steroids (\\> 0.5 mg\u002Fkg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and\u002For infection.\n* Any medical condition that could compromise participation in the study according to the investigator's assessment.\n* Known history of HIV infection in the mother.\n* Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.","ALL","0 Days","21 Days",{"count":147,"type":148},23,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened.\n\nAll patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs.\n\nFunding source: FDA OOPD",[154],"Congenital Cytomegaloviral (CMV) Disease","2026-03-24",{"date":157,"type":158},"2026-03-30","ACTUAL",{"date":160,"type":158},"2023-07-01",{"date":162,"type":148},"2028-10-31",{"name":5,"class":6},4]