[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592027":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":18,"collaborators":10,"id":20,"slug":21,"hasResults":22,"nctId":23,"briefTitle":24,"officialTitle":25,"acronym":26,"eligibilityCriteria":27,"healthyVolunteers":22,"sex":28,"minAge":29,"maxAge":10,"enrollmentInfo":30,"targetDuration":10,"studyType":33,"phases":10,"briefSummary":34,"conditions":35,"keywords":38,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":10},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Adult patients with relapsed or refractory diffuse large B-cell lymphoma",null,[12],"Other: Blood sampling",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":10},"Blood sampling","Before and after fludarabine infusion",[9],{"type":19,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100592027","impact-of-lymphodepletion-regimen-on-the-response-to-car-t-cells-in-patients-with-with-relapsedrefractory-large-b-cell-lymphoma-100592027",false,"NCT06988085","Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed\u002FRefractory Large B-cell Lymphoma","Impact de la lymphodéplétion Dans la réponse Aux CAR T-cells Dans Les Lymphomes B Agressifs réfractaires ou en Rechute","CARLYM","Inclusion Criteria:\n\n* Adult patient aged 18 years and older\n* Treated with commercial CAR T-cells (Lisocabtagene maraleucel, Tisagenlecleucel, or Axicabtagene ciloleucel), with standard lymphodepletion consisting of Fludarabine and Cyclophosphamide\n* Presenting with aggressive large B-cell lymphoma that is refractory or has relapsed after at least one line of treatment\n* Creatinine clearance \\> 50 ml\u002Fmin (Cockcroft CKD-EPI)\n\nExclusion Criteria:\n\n* Weight ≤ 50 kg\n* Out-of-specification reinfusion product\n* Individual participating in another study with an ongoing exclusion period at the time of inclusion\n* Person under guardianship or curatorship, or deprived of liberty by judicial or administrative decision\n* Patient's opposition to the study","ALL","18 Years",{"count":31,"type":32},42,"ESTIMATED","OBSERVATIONAL","CAR T cells therapy has transformed the prognostic of relapsed\u002Frefractory large B cells lymphomas. Relapse however is still high and multiple causes have been studied. CAR expansion seems to be necessary to for response and lymphodepletion type and exposure, notably to fludarabine, associated with expansion and response.\n\nThe aim of the study is to analyse prospectivaly Fludarabine and cyclophosphamide exposure and correlate exposure to expansion, therapeutic response and survival.",[36,37],"Large B Cell Lymphoma","CAR T Cell",[39,40,41,42],"Large B cell lymphoma","CAR T cell","Lymphodepletion","Fludarabine exposure","NOT_YET_RECRUITING","2025-05-16",{"date":46,"type":47},"2025-05-23","ACTUAL",{"date":49,"type":32},"2025-05-30",{"date":51,"type":32},"2027-05-30",{"name":5,"class":6}]