[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adv-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":20,"type":21},69,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31],"CMV","AdV Infection","AdV Reactivation","Adenovirus","Cytomegalovirus Infections","NOT_YET_RECRUITING","2025-11-06",{"date":35,"type":36},"2025-11-10","ACTUAL",{"date":38,"type":21},"2026-12-01",{"date":40,"type":21},"2032-12-01",{"name":42,"class":43},"New York Medical College","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100426407","phase-3-multivirus-specific-t-cell-transfer-post-sct-vs-adv-cmv-and-ebv-infections-100426407","NCT04832607","Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections","Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial","TRACE","Inclusion Criteria:\n\n1. Adult or paediatric patients (\\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis.\n2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.\n3. Written informed consent given (patient or legal representative) prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Patient with acute GvHD \\> grade II or extensive chronic GvHD at the time of IMP transfer\n2. Patient receiving steroids (\\>1 mg\u002Fkg BW Prednisone equivalent) at Screening.\n3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells\u002Fkg BW in case of T-cell depleted HSCT is not considered an exclusion criterion.\n4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study\n6. Any medical condition which could compromise participation in the study according to the investigator's assessment\n7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study\n8. Second line or experimental antiviral treatment other than Ganciclovir\u002FValganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor\n9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.\n10. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8).\n\n    Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study.\n11. Known hypersensitivity to iron dextran\n12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.","2 Months",{"count":54,"type":21},149,[24],"Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.",[28,58,59,60],"EBV Infection","CMV Infection","Stem Cell Transplant Complications","RECRUITING","2025-07-15",{"date":64,"type":36},"2025-07-18",{"date":66,"type":36},"2019-08-27",{"date":68,"type":21},"2028-09",{"name":70,"class":43},"Tobias Feuchtinger",33]