[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":26,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"New York Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care Medication","ACTIVE_COMPARATOR","Patients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician.",[13],"Drug: Standard of Care Antiviral medications",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)","EXPERIMENTAL","Patients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs.",[13,19],"Biological: Viral CTLs",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Standard of Care Antiviral medications","Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)",[9,15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BIOLOGICAL","Viral CTLs","ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions",[15],[33],{"name":34,"affiliation":5,"role":35},"Mitchell Cairo, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","914-594-2150","mitchell_cairo@nymc.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Lauren Harrison, RN","617-285-7844","lauren_harrison@nymc.edu",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100610314","phase-3-phase-3-randomized-trial-for-refractory-adv-or-cmv-infection-with-family-matched-ctls-and-standard-of-care-soc-vs-soc-alone-100610314",false,"NCT07225972","Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone","An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection\u002FViremia","Patient Eligibility Cohort 1 (ADV) -Patients with ADV infections (Cohort 1) (pneumonitis, hepatitis, cystitis, and\u002For colitis) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (\\> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-viral therapies including one or more of the following: \\> grade 2 renal insufficiency secondary to cidofovir and\u002For other \\> grade 2 toxicities secondary to cidofovir AND\u002FOR Known resistance to cidofovir\n\nPatient Eligibility (Cohort 2) (CMV)\n\n-Patients with CMV infections (pneumonitis, hepatitis, colitis) with one or more of the following: Increasing or persistent CMV RT-PCR DNA (\\>1000 copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-CMV antibiotic therapies: ANC \\> 500\u002Fmm3 secondary to ganciclovir AND\u002FOR \\> grade 2 renal toxicity secondary to either foscarnet or cidofovir AND\u002FOR Known resistance to ganciclovir and\u002For foscarnet\n\n* Consent: written informed consent given (by patient or legal representative) prior to any study related procedures\n* Performance Status \\>30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 years (BOTH COHORTS)\n* Age: 0.01 to 30.00 years (BOTH COHORTS)\n* Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is \\>0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2).\n* Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor \\> 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND\n* Obtained informed consents by donor or donor legally authorized representative prior to donor collection\n\nPatient Exclusion Criteria (Both Cohorts)\n\n* Patient with acute GVHD \\> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CTL infusion.\n* Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.\n* Patient with poor performance status determined by Karnofksy (patients \\> 16 yrs) or Lansky (patients \\\u003C 16 years) score \\\u003C 30%.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections.\n* Any known medical condition which cold compromise participation in the study according to investigators assessment.\n* Known AIDS or uncontrolled HIV infection\n* Known hypersensitivity to iron dextran\n* Encephalitis and\u002For retinitis","ALL","1 Day","30 Years",{"count":58,"type":59},69,"ESTIMATED","INTERVENTIONAL",[62],"PHASE3","Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.",[65,66,67,68,69],"CMV","AdV Infection","AdV Reactivation","Adenovirus","Cytomegalovirus Infections","NOT_YET_RECRUITING","2025-11-06",{"date":73,"type":74},"2025-11-10","ACTUAL",{"date":76,"type":59},"2026-12-01",{"date":78,"type":59},"2032-12-01",{"name":5,"class":6}]