protocolSection identificationModule nctId: NCT06271057, orgStudyIdInfo id: CARMOD, briefTitle: Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2027-10-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: The Lymphoma Academic Research Organisation, class: OTHER, collaborators name: Lymphoma Study Association, descriptionModule briefSummary: This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator., conditionsModule conditions: Diffuse Large B-cell Lymphoma Refractory, conditions: Refractory Primary Mediastinal Large B-Cell Lymphoma, conditions: Refractory Transformed B-cell Non-Hodgkin Lymphoma, conditions: Refractory High Grade B-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: golcadomide, outcomesModule primaryOutcomes measure: Complete metabolic response rate (CMR rate), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Duration of response (DR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Time To Next anti-Lymphoma Treatment (TTNLT), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of Adverse Events and Serious Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Henri Mondor, city: Créteil, zip: 94010, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Chu Dijon Bourgogne, city: Dijon, zip: 21000, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chu de Grenoble, city: La Tronche, zip: 38700, country: France, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Chru de Lille, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Institut Paoli Calmettes, city: Marseille, zip: 13273, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Chu de Montpellier, city: Montpellier, zip: 34090, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Chu de Nantes, city: Nantes, zip: 44093, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hopital Saint-Louis, city: Paris, zip: 75475, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Chu de Bordeaux, city: Pessac, zip: 33604, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Chu Pontchaillou, city: Rennes, zip: 35033, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Centre Henri Becquerel, city: Rouen, zip: 76038, country: France, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Iuct Oncopole, city: Toulouse, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Chu Brabois, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False