nctId: NCT06299553 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) overallStatus: RECRUITING date: 2023-12-04 date: 2025-06-30 date: 2027-06-30 date: 2024-03-08 date: 2024-03-12 name: Incyte Biosciences Italy S.r.l class: INDUSTRY 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. conditions: DLBCL - Diffuse Large B Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Progression free survival (PFS) measure: Baseline Characteristics measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Time to next treatment (TTNT) measure: Time to response measure: Overall Survival (OS) measure: Disease Control Rate (DCR) measure: Event Free Survival (EFS) measure: Progression-Free-Survival 2 (PFS2) measure: Information of which treatment the patients will get after tafasitamab discontinuation measure: Safety of tafasitamab combined with lenalidomide measure: Safety of tafasitamab in monotherapy measure: Describe the treatment adherence of lenalidomide and dose reduction. measure: Health-Related Quality of Life (HRQoL) measure: Health-Related Quality of Life (HRQoL) measure: Health economics - Hospitalization measure: Health economics - DLBCL treatment measure: Health economics - Concomitant Treatments measure: Health economics - Monitoring activities measure: Health economics - monitoring activities performed after patients' discharge measure: Health economics - Adverse event treatment measure: Health economics - Unplanned specialist visits measure: Exploratory objectives measure: Exploratory objectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Incyte Biosciences Italy S.r.l status: RECRUITING city: Milan zip: 20122 country: Italy name: Nicola Battaglia role: CONTACT phone: +39 3429513636 email: NBattaglia@incyte.com name: Mario Lapecorella role: CONTACT email: MLapecorella@incyte.com name: Pier Luigi Zinzani role: PRINCIPAL_INVESTIGATOR name: Eliana Valentina Liardo role: PRINCIPAL_INVESTIGATOR name: Paolo Corradini role: PRINCIPAL_INVESTIGATOR name: Enrico Derenzini role: PRINCIPAL_INVESTIGATOR name: Francesca Gaia Rossi Dardanoni role: PRINCIPAL_INVESTIGATOR name: Andrès Ferreri role: PRINCIPAL_INVESTIGATOR name: Leonardo Flenghi role: PRINCIPAL_INVESTIGATOR name: Caterina Patti role: PRINCIPAL_INVESTIGATOR name: Maurizio Musso role: PRINCIPAL_INVESTIGATOR name: Annalisa Chiarenza role: PRINCIPAL_INVESTIGATOR name: Adalberto Ibatici role: PRINCIPAL_INVESTIGATOR name: Michele Spina role: PRINCIPAL_INVESTIGATOR name: Alice Di Rocco role: PRINCIPAL_INVESTIGATOR name: Maria Christina Cox role: PRINCIPAL_INVESTIGATOR name: Stefan Hohaus role: PRINCIPAL_INVESTIGATOR name: Andrea Bernardelli role: PRINCIPAL_INVESTIGATOR name: Francesco Piazza role: PRINCIPAL_INVESTIGATOR name: Domenico Pastore role: PRINCIPAL_INVESTIGATOR name: Giuseppe Tarantini role: PRINCIPAL_INVESTIGATOR name: Daniela Dessì role: PRINCIPAL_INVESTIGATOR name: Sofya Kovalchuk role: PRINCIPAL_INVESTIGATOR name: Alberto Fabbri role: PRINCIPAL_INVESTIGATOR name: Antonio Pinto role: PRINCIPAL_INVESTIGATOR name: Ferdinando Frigeri role: PRINCIPAL_INVESTIGATOR name: Mario Annunziata role: PRINCIPAL_INVESTIGATOR name: Elsa Pennese role: PRINCIPAL_INVESTIGATOR name: Caterina Cecilia Stelitano role: PRINCIPAL_INVESTIGATOR name: Mattia Novo role: PRINCIPAL_INVESTIGATOR name: Manuela Zanni role: PRINCIPAL_INVESTIGATOR name: Guido Gini role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False