[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482635":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":52,"responsibleParty":118,"collaborators":47,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":47,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":47,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":47,"overallStatus":55,"whyStopped":47,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"New York Medical College","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Biological: CMV Cytotoxic T-Lymphocytes","Drug: Anti-viral Therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2 Antiviral medication + CMV CTLs","Patients will receive both anti-viral medication and CMV CTLs",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Cohort 2 Antiviral medication only","ACTIVE_COMPARATOR","Patients will only receive anti-viral therapy",[14],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9,16],[31],"CTLs",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"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",[9,16,20],[38],"valganciclovir, ganciclovir",[40],{"name":41,"affiliation":5,"role":42},"Mitchell Cairo, MD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","914-594-2150",null,"mitchell_cairo@nymc.edu",{"name":50,"role":45,"phone":47,"phoneExt":47,"email":51},"Edo Schaefer, MD","eshaefe@nymc.edu",[53,74,88,104],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-118.24368,34.05223,{"lat":65,"lon":64},[68,71],{"name":69,"role":45,"phone":47,"phoneExt":47,"email":70},"Neena Kapoor, MD","nkapoor@chla.usc.edu",{"name":72,"role":45,"phone":47,"phoneExt":47,"email":73},"Phillippe Friedlich, MD","pfriedlich@chla.usc.edu",{"facility":75,"status":55,"city":76,"state":77,"zip":78,"country":59,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Washington University","St Louis","Missouri","63130",{"type":62,"coordinates":80},[81,82],-90.19789,38.62727,{"lat":82,"lon":81},[85],{"name":86,"role":45,"phone":47,"phoneExt":47,"email":87},"Carol Kao, MD","kaoc@wustl.edu",{"facility":5,"status":55,"city":89,"state":90,"zip":91,"country":59,"countryCode":60,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Valhalla","New York","10595",{"type":62,"coordinates":93},[94,95],-73.77513,41.07482,{"lat":95,"lon":94},[98,100],{"name":41,"role":45,"phone":99,"phoneExt":47,"email":48},"914-594-3650",{"name":101,"role":45,"phone":102,"phoneExt":47,"email":103},"Lauren Harrison, MSN","617-285-7844","lauren_harrison@nymc.edu",{"facility":105,"status":55,"city":106,"state":107,"zip":108,"country":59,"countryCode":60,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Nationwide Children's Hosptial","Columbus","Ohio","43205",{"type":62,"coordinates":110},[111,112],-82.99879,39.96118,{"lat":112,"lon":111},[115],{"name":116,"role":45,"phone":47,"phoneExt":47,"email":117},"Masako Shimamura, MD","masako.shimamura@nationwidechildrens.org",{"type":42,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Mitchell Cairo","Principal Investigator","100482635","phase-2-cmv-ctls-in-neonates-with-cmv-infection-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":132,"type":133},23,"ESTIMATED","INTERVENTIONAL",[136],"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",[139],"Congenital Cytomegaloviral (CMV) Disease","2026-03-24",{"date":142,"type":143},"2026-03-30","ACTUAL",{"date":145,"type":143},"2023-07-01",{"date":147,"type":133},"2028-10-31",{"name":5,"class":6},4]