protocolSection identificationModule nctId: NCT06299553, orgStudyIdInfo id: INCB88888-040 PRO-MIND, briefTitle: Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Incyte Biosciences Italy S.r.l, class: INDUSTRY, descriptionModule briefSummary: The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL., conditionsModule conditions: DLBCL - Diffuse Large B Cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Baseline Characteristics, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Time to next treatment (TTNT), secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Progression-Free-Survival 2 (PFS2), secondaryOutcomes measure: Information of which treatment the patients will get after tafasitamab discontinuation, secondaryOutcomes measure: Safety of tafasitamab combined with lenalidomide, secondaryOutcomes measure: Safety of tafasitamab in monotherapy, secondaryOutcomes measure: Describe the treatment adherence of lenalidomide and dose reduction., secondaryOutcomes measure: Health-Related Quality of Life (HRQoL), secondaryOutcomes measure: Health-Related Quality of Life (HRQoL), secondaryOutcomes measure: Health economics - Hospitalization, secondaryOutcomes measure: Health economics - DLBCL treatment, secondaryOutcomes measure: Health economics - Concomitant Treatments, secondaryOutcomes measure: Health economics - Monitoring activities, secondaryOutcomes measure: Health economics - monitoring activities performed after patients' discharge, secondaryOutcomes measure: Health economics - Adverse event treatment, secondaryOutcomes measure: Health economics - Unplanned specialist visits, secondaryOutcomes measure: Exploratory objectives, secondaryOutcomes measure: Exploratory objectives, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Incyte Biosciences Italy S.r.l, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Nicola Battaglia, role: CONTACT, phone: +39 3429513636, email: NBattaglia@incyte.com, contacts name: Mario Lapecorella, role: CONTACT, email: MLapecorella@incyte.com, contacts name: Pier Luigi Zinzani, role: PRINCIPAL_INVESTIGATOR, contacts name: Eliana Valentina Liardo, role: PRINCIPAL_INVESTIGATOR, contacts name: Paolo Corradini, role: PRINCIPAL_INVESTIGATOR, contacts name: Enrico Derenzini, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Gaia Rossi Dardanoni, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrès Ferreri, role: PRINCIPAL_INVESTIGATOR, contacts name: Leonardo Flenghi, role: PRINCIPAL_INVESTIGATOR, contacts name: Caterina Patti, role: PRINCIPAL_INVESTIGATOR, contacts name: Maurizio Musso, role: PRINCIPAL_INVESTIGATOR, contacts name: Annalisa Chiarenza, role: PRINCIPAL_INVESTIGATOR, contacts name: Adalberto Ibatici, role: PRINCIPAL_INVESTIGATOR, contacts name: Michele Spina, role: PRINCIPAL_INVESTIGATOR, contacts name: Alice Di Rocco, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Christina Cox, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefan Hohaus, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Bernardelli, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesco Piazza, role: PRINCIPAL_INVESTIGATOR, contacts name: Domenico Pastore, role: PRINCIPAL_INVESTIGATOR, contacts name: Giuseppe Tarantini, role: PRINCIPAL_INVESTIGATOR, contacts name: Daniela Dessì, role: PRINCIPAL_INVESTIGATOR, contacts name: Sofya Kovalchuk, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Fabbri, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Pinto, role: PRINCIPAL_INVESTIGATOR, contacts name: Ferdinando Frigeri, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario Annunziata, role: PRINCIPAL_INVESTIGATOR, contacts name: Elsa Pennese, role: PRINCIPAL_INVESTIGATOR, contacts name: Caterina Cecilia Stelitano, role: PRINCIPAL_INVESTIGATOR, contacts name: Mattia Novo, role: PRINCIPAL_INVESTIGATOR, contacts name: Manuela Zanni, role: PRINCIPAL_INVESTIGATOR, contacts name: Guido Gini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False