protocolSection identificationModule nctId: NCT06339255, orgStudyIdInfo id: INT 180/19, briefTitle: Italian Observational Study on CAR-T Therapy for Lymphoma, acronym: CART-SIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-10-30, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Paolo Corradini, class: OTHER, collaborators name: Annalisa Chiappella, collaborators name: Cristiana Carniti, collaborators name: Anna Dodero, descriptionModule briefSummary: The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity., conditionsModule conditions: Diffuse Low Grade B-Cell Lymphoma, conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL), conditions: Mantle Cell Lymphoma, conditions: Follicular Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice, primaryOutcomes measure: Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice, secondaryOutcomes measure: Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria., secondaryOutcomes measure: Evaluation of Outcome: Overall survival (OS), according to Lugano criteria., secondaryOutcomes measure: Evaluation of Outcome: Progression free survival (PFS), secondaryOutcomes measure: Evaluation of Outcome: duration of response (DoR), secondaryOutcomes measure: Evaluation of Outcome: Overall Response rate (ORR), secondaryOutcomes measure: Evaluation of Outcome: Overall survival (OS), secondaryOutcomes measure: Evaluation of Outcome: non-relapse mortality (NRM), secondaryOutcomes measure: Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications, secondaryOutcomes measure: Evaluation of bridging therapy: safety, secondaryOutcomes measure: Evaluation of bridging therapy: efficay, secondaryOutcomes measure: Evaluation of salvage therapy after CAR-T failure, secondaryOutcomes measure: Evaluation of salvage therapy after CAR-T failure, secondaryOutcomes measure: Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety), secondaryOutcomes measure: Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products, otherOutcomes measure: Characterization of biomarkers of early response (circulating tumor cell free DNA versus PET and CT scans), otherOutcomes measure: Characterization of toxicity biomarkers, otherOutcomes measure: Analysis of the immune reconstitution, otherOutcomes measure: Analysis of the CAR-T expression, otherOutcomes measure: Influence of PET quantitative parameters: tMTV changes between baseline and +30 and +90 after CAR T-cell infusion (ΔSUV max) related to outcome, otherOutcomes measure: Influence of PET quantitative parameters: Distance max, otherOutcomes measure: Influence of PET quantitative parameters: Distance max bulky, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale Tumori, status: RECRUITING, city: Milan, zip: 20133, country: Italy, contacts name: Paolo Corradini, Professor, role: CONTACT, phone: +39 02 2390 2950, email: paolo.corradini@istitutotumori.mi.it, contacts name: Anisa Bermema, PhD, role: CONTACT, phone: +39 02 2390 3145, email: anisa.bermema@istitutotumori.mi.it, contacts name: Annalisa Chiappella, MD, role: SUB_INVESTIGATOR, contacts name: Anna Dodero, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False