[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643725":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":47,"armGroups":48,"interventions":54,"overallOfficials":43,"centralContacts":60,"locations":66,"responsibleParty":82,"collaborators":43,"id":86,"slug":43,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":43,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":43,"briefSummary":99,"conditions":100,"keywords":43,"overallStatus":69,"whyStopped":43,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"Investigate immune status in correlation with ATLG","Longitudinal IR monitoring (T\u002FB\u002FNK lymphocyte subpopulations including naïve- memory- stem\u002Fmemory- regulatory subsets, cytokine profile, NFL\u002FMacrophages) on PB","before mobilization, before conditioning, +1\u002F3\u002F6\u002F12 months after HSCT.",{"measure":10,"description":14,"timeFrame":15},"Assessment of ATLG levels \\& kinetics","before and 30' after the end of ATLG dose, day0, day1, weekly for 4 weeks.",[17,21,25,29,33,37,40],{"measure":18,"description":19,"timeFrame":20},"Assess clinically relevant viral infections in correlation with viral specific IR","Assessment of pathogen-specific responses (CMV specific T cells by ELISpot) and occurrence of clinically relevant viral infections (CMV, EBV; ECIL 10 guidelines).","before mobilization, +1 month after HSCT within the first year after HSCT.",{"measure":22,"description":23,"timeFrame":24},"To assess HSCT and neurological outcomes","Transplant-related mortality (TRM)","at 100 days and 1-year",{"measure":26,"description":27,"timeFrame":28},"Assessment of Progression Free Survival (PFS)","Assessment of general HSCT outcomes (PFS)","at 1-year",{"measure":30,"description":31,"timeFrame":32},"Assessment of Overall survival (OS)","Assessment of general HSCT outcomes - OS","At 1 year",{"measure":34,"description":35,"timeFrame":36},"neurological status- Expanded Disability Status Scale (EDSS)","Expanded Disability Status Scale (EDSS)","at 100 days, 6 months and 1-year",{"measure":38,"description":38,"timeFrame":39},"neurological status - neurological progression","at 1 year",{"measure":41,"description":42,"timeFrame":32},"neurological status -No Evidence of Disease Activity","No Evidence of Disease Activity (NEDA)",null,{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":45,"timePerspective":46,"maskingInfo":43},"CASE_ONLY","PROSPECTIVE","The study will involve 20 MS patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous HSCT is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy DMTs or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.\n\nPatients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg\u002Fkg over 3 days: 10 mg\u002Fkg on days -3, -2 and -1).",[49],{"label":50,"type":43,"description":51,"interventionNames":52},"Multiple Sclerosis patients treated with autologous HSCT as standard of care","The study will involve 20 Multiple Sclerosis (MS) patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous Hematopoietic stem cell transplantation (HSCT) is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy Disease modifying therapies (DMTs) or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.",[53],"Drug: ATLG administration",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":43},"DRUG","ATLG administration","Patients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg\u002Fkg over 3 days: 10 mg\u002Fkg on days -3, -2 and -1).",[50],[61],{"name":62,"role":63,"phone":64,"phoneExt":43,"email":65},"Raffaella Greco","CONTACT","+39 02-2643-3903","greco.raffaella@hsr.it",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":71,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"IRCCS Ospedale San Raffaele","RECRUITING","Milan","Italy","20132","IT",{"type":75,"coordinates":76},"Point",[77,78],12.59836,42.78235,{"lat":78,"lon":77},[81],{"name":62,"role":63,"phone":64,"phoneExt":43,"email":65},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Ciceri Fabio","Professor","100643725",false,"NCT07635693","ATLG Levels in Autologous HSCT for Multiple Sclerosis","ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis","ATLG-MS","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Adult patients (age \\>\u002F= 18y)\n* Diagnosis of MS\n* Confirmed program of autologous HSCT according to standard EBMT indications (any conditioning regimen considered standard, BEAM or Cyclophosphamide)\n* ATLG (total dose 30 mg\u002Fkg over 3 days: 10 mg\u002Fkg on days -3, -2 and -1) in the conditioning regimen.\n\nExclusion Criteria:\n\n* Subjects that did not accept to sign the informed consent.\n* Use of ATG.\n* Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)","ALL","18 Years",{"count":96,"type":97},20,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational, biological, multicenter study to investigate IR profile, ATLG dynamics, main HSCT and disease outcomes in MS. This study will provide a preliminary descriptive evaluation of key study parameters, including ATLG pharmacokinetics and immune reconstitution trends, as well as an initial assessment of variability (e.g., dispersion of immunological biomarkers), to support the interpretation of results and the design of future studies. Since this is an observational study, no clinical decision will be made, and the interim analysis will not have an impact of the study conduction, and it will not be a stopping rule.",[101,102,103],"Multiple Sclerosis","Autologous Hematopoietic Stem Cell Transplant","ATLG","2026-06-04",{"date":106,"type":107},"2026-06-09","ACTUAL",{"date":109,"type":107},"2026-05-04",{"date":111,"type":97},"2029-05-04",{"name":84,"class":6},1]