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High rate of durable responses with undetectable minimal residual disease with front-line venetoclax and rituximab in young, fit patients with chronic lymphocytic leukemia and an adverse biological profile: results of the GIMEMA phase II LLC1518 - VERITAS study.
Mauro, Francesca R; Starza, Irene Della; Messina, Monica; Reda, Gianluigi; Trentin, Livio; Coscia, Marta; Sportoletti, Paolo; Orsucci, Lorella; Arena, Valentina; Casaluci, Gloria Margiotta; Marasca, Roberto; Murru, Roberta; Laurenti, Luca; Ilariucci, Fiorella; Stelitano, Caterina; Mannina, Donato; Massaia, Massimo; Rigolin, Gian Matteo; Scarfò, Lydia; Marchetti, Monia; Levato, Luciano; Tani, Monica; Arcari, Annalisa; Musuraca, Gerardo; Deodato, Marina; Galieni, Piero; Patrizi, Valeria Belsito; Gottardi, Daniela; Liberati, Anna Marina; Giordano, Annamaria; Molinari, Maria Chiara; Pietrasanta, Daniela; Mattiello, Veronica; Visentin, Andrea; Vitale, Candida; Albano, Francesco; Neri, Antonino; De Novi, Lucia Anna; De Propris, Maria Stefania; Nanni, Mauro; Del Giudice, Ilaria; Guarini, Anna; Fazi, Paola; Vignetti, Marco; Piciocchi, Alfonso; Cuneo, Antonio; Foà, Robin.
Affiliation
  • Mauro FR; Hematology, Department of Translational and Precision Medicine, Sapienza University. mauro@bce.uniroma1.it.
  • Starza ID; Hematology, Department of Translational and Precision Medicine, Sapienza University, Rome; GIMEMA Foundation.
  • Messina M; GIMEMA Foundation.
  • Reda G; Hematology Department, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan.
  • Trentin L; Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua.
  • Coscia M; Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences, University of Torino.
  • Sportoletti P; Department of Medicine and Surgery, Institute of Hematology, Centro di Ricerca Emato Oncologica (CREO), University of Perugia, Perugia.
  • Orsucci L; Department of Hematology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino.
  • Arena V; GIMEMA Foundation.
  • Casaluci GM; Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale and AOU Maggiore della Carità, Novara.
  • Marasca R; Hematology Unit, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia.
  • Murru R; Hematology and Stem Cell Transplantation Unit, Ospedale A. Businco, ARNAS "G. Brotzu", Cagliari.
  • Laurenti L; Fondazione Policlinico Universitario A Gemelli, IRCCS.
  • Ilariucci F; Division of Hematology, Hematology, Arcispedale Santa Maria Nuova, Reggio Emilia.
  • Stelitano C; Department of Hematology, Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria.
  • Mannina D; Division of Hematology, Azienda Ospedaliera Papardo, Messina.
  • Massaia M; Division of Hematology, Santa Croce e Carle Hospital, Via Michele Coppino 26, 12100 Cuneo.
  • Rigolin GM; Hematology Section, St. Anna University Hospital, Ferrara.
  • Scarfò L; Strategic Research Program on CLL, IRCCS Ospedale San Raffaele and Università Vita- Salute San Raffaele, Milan.
  • Marchetti M; Hematology and Transplant Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, University of Eastern Pedemont, Alessandria.
  • Levato L; Department of Hematology, Pugliese Ciaccio Hospital, Catanzaro.
  • Tani M; Division of Hematology, Santa Maria delle Croci Hospital, Ravenna.
  • Arcari A; Division of Hematology, Guglielmo da Saliceto Hospital, Piacenza.
  • Musuraca G; Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori-IRST, Meldola.
  • Deodato M; ASST Grande Ospedale Metropolitano Niguarda, Milan.
  • Galieni P; Hematology, Mazzoni Hospital, Ascoli Piceno.
  • Patrizi VB; Hematology Department, Umberto I Hospital, Nocera Inferiore (Salerno).
  • Gottardi D; A.O. Ordine Mauriziano di Torino.
  • Liberati AM; Università degli Studi di Perugia, Azienda Ospedaliera Santa Maria di Terni, Terni.
  • Giordano A; University of Bari "Aldo Moro," Hematology and Stem Cell Transplantation Unit, Department of Emergency and Organ Transplantation, Bari.
  • Molinari MC; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • Pietrasanta D; Hematology and Transplant Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, University of Eastern Pedemont, Alessandria.
  • Mattiello V; Hematology Department, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan.
  • Visentin A; Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua.
  • Vitale C; Division of Hematology, A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences, University of Torino.
  • Albano F; University of Bari "Aldo Moro," Hematology and Stem Cell Transplantation Unit, Department of Emergency and Organ Transplantation, Bari.
  • Neri A; Hematology Department, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan.
  • De Novi LA; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • De Propris MS; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • Nanni M; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • Del Giudice I; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • Guarini A; Hematology, Department of Translational and Precision Medicine, Sapienza University.
  • Fazi P; GIMEMA Foundation.
  • Vignetti M; GIMEMA Foundation.
  • Piciocchi A; GIMEMA Foundation.
  • Cuneo A; Hematology Section, St. Anna University Hospital, Ferrara.
  • Foà R; Hematology, Department of Translational and Precision Medicine, Sapienza University.
Haematologica ; 108(8): 2091-2100, 2023 08 01.
Article in En | MEDLINE | ID: mdl-36632738
The GIMEMA phase II LLC1518 VERITAS trial investigated the efficacy and safety of front-line, fixed-duration venetoclax and rituximab (VenR) in combination in young (≤65 years), fit patients with chronic lymphocytic leukemia and unmutated IGHV and/or TP53 disruption. Treatment consisted of the venetoclax ramp-up, six monthly courses of the VenR combination, followed by six monthly courses of venetoclax as a single agent. A centralized assessment of minimal residual disease (MRD) was performed by allele-specific oligonucleotide polymerase chain reaction assay on the peripheral blood and bone marrow at the end of treatment (EOT) and during the follow-up. The primary endpoint was the complete remission rate at the EOT. Seventy-five patients were enrolled; the median age was 54 years (range, 38-65), 96% had unmutated IGHV, 12% had TP53 disruption, and 4% had mutated IGHV with TP53 disruption. The overall response rate at the EOT was 94.7%, with a complete remission rate of 76%. MRD was undetectable in the peripheral blood of 69.3% of patients and in the bone marrow of 58.7% of patients. The 12-month MRD-free survival in the 52 patients with undetectable MRD in the peripheral blood at the EOT was 73.1%. After a median follow-up of 20.8 months, no cases of disease progression were observed. Three patients had died, two due to COVID-19 and one due to tumor lysis syndrome. The first report of the VERITAS study shows that front-line VenR was associated with a high rate of complete remissions and durable response with undetectable MRD in young patients with chronic lymphocytic leukemia and unfavorable genetic characteristics. ClinicalTrials.gov identifier: NCT03455517.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Lymphocytic, Chronic, B-Cell / COVID-19 Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans / Middle aged Language: En Journal: Haematologica Year: 2023 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Lymphocytic, Chronic, B-Cell / COVID-19 Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans / Middle aged Language: En Journal: Haematologica Year: 2023 Type: Article