{
    "abstract": "Access to allogeneic haematopoietic stem-cell transplantation (HSCT) remains challenging for older patients (aged >60 years) with acute myeloid leukaemia. We aimed to evaluate the efficacy of venetoclax plus decitabine as first-line therapy and bridge to transplantation in this patient population.\nThis multicentre, single-arm, phase 2 trial was conducted in 20 Gruppo Italiano Trapianto Midollo Osseo (GITMO) centres in Italy. Patients aged \u226560 and <75 years, with newly diagnosed acute myeloid leukaemia categorised as intermediate or high risk according to 2016 WHO and 2017 European LeukemiaNet, an ECOG performance status of less than 2, and considered fit for allogeneic HSCT were included. Patients received oral venetoclax with a 3-day ramp-up: 100 mg on day 1, 200 mg on day 2, and 400 mg once per day from day 3 of cycle one, and then every 28 days of each cycle (two to four in total). Decitabine was administered intravenously at a dose of 20 mg/m\nBetween June 1, 2021, and Dec 30, 2022, 93 patients were enrolled and started venetoclax plus decitabine induction (44 [47%] at intermediate risk and 49 [53%] at high risk). The median age was 68\u00b75 (IQR 60\u00b73-74\u00b77). All 93 participants were White, of whom 43 (46%) were female and 50 (54%) were male. The median follow-up was 236 days (IQR 121-506). 64 (69%) of 93 patients reached complete remission and 53 (57%) underwent allogeneic HSCT in complete remission. 53 (83%) of 64 with a complete remission underwent allogeneic HSCT. Five (8%) of 64 patients in complete remission relapsed before transplantation and four died as a consequence. Adverse events (grade \u22653) occurred in 49 (53%) of 93 patients. The most common adverse events were infections (including pneumonia, bacterial sepsis, and SARS-CoV-2 causing seven deaths among 28 [57%] of 49 patients), neutropenia (17 [35%]), thrombocytopenia (two [4%], including one fatal CNS bleeding), and cardiac events (four [8%], including one fatal heart failure). No treatment-related deaths were observed.\nVenetoclax plus decitabine induction can significantly enhance the feasibility of allogeneic HSCT in older patients with acute myeloid leukaemia who are deemed fit for transplantation.\nAbbVie and Johnson & Johnson.",
    "authors": [
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy. Electronic address: domenico.russo@unibs.it.",
            "firstname": "Domenico",
            "initials": "D",
            "lastname": "Russo"
        },
        {
            "affiliation": "Department of Molecular Medicine, Division of Hematology, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.",
            "firstname": "Nicola",
            "initials": "N",
            "lastname": "Polverelli"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy; Centro di Ricerca Emato-Oncologica AIL, ASST Spedali Civili di Brescia, Brescia, Italy; National Center for Gene Therapy and Drug based on RNA Technology, Padova, Italy.",
            "firstname": "Simona",
            "initials": "S",
            "lastname": "Bernardi"
        },
        {
            "affiliation": "Centro Trapianti Midollo Osseo, Azienda Sanitaria Locale di Pescara, Pescara, Italy.",
            "firstname": "Stella",
            "initials": "S",
            "lastname": "Santarone"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Mirko",
            "initials": "M",
            "lastname": "Farina"
        },
        {
            "affiliation": "Division of Hematology, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Erika",
            "initials": "E",
            "lastname": "Borlenghi"
        },
        {
            "affiliation": "MTN Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.",
            "firstname": "Francesco",
            "initials": "F",
            "lastname": "Onida"
        },
        {
            "affiliation": "Bone Marrow Transplantation Unit, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.",
            "firstname": "Luca",
            "initials": "L",
            "lastname": "Castagna"
        },
        {
            "affiliation": "Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.",
            "firstname": "Stefania",
            "initials": "S",
            "lastname": "Bramanti"
        },
        {
            "affiliation": "IRCCS Ospedale Casa Sollievo della Sofferenza, Foggia, Italy.",
            "firstname": "Angelo Michele",
            "initials": "AM",
            "lastname": "Carella"
        },
        {
            "affiliation": "Department of Hematology, S Croce e Carle Hospital, Cuneo, Italy.",
            "firstname": "Roberto",
            "initials": "R",
            "lastname": "Sorasio"
        },
        {
            "affiliation": "Centro Unico Trapianti, Division of Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy.",
            "firstname": "Massimo",
            "initials": "M",
            "lastname": "Martino"
        },
        {
            "affiliation": "Centro Unico Trapianti, Division of Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy.",
            "firstname": "Caterina",
            "initials": "C",
            "lastname": "Alati"
        },
        {
            "affiliation": "Clinica di Ematologia Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy.",
            "firstname": "Attilio",
            "initials": "A",
            "lastname": "Olivieri"
        },
        {
            "affiliation": "UO Ematologia e Terapie Cellulari, IRCCS Azienda Ospedaliera Universitaria San Martino, Genova, Italy.",
            "firstname": "Germana",
            "initials": "G",
            "lastname": "Beltrami"
        },
        {
            "affiliation": "IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia Ser\u00e0gnoli, Bologna, Italy.",
            "firstname": "Antonio",
            "initials": "A",
            "lastname": "Curti"
        },
        {
            "affiliation": "Division of Hematology, BMT Unit, AOU Policlinico G Rodolico S Marco, Catania, Italy.",
            "firstname": "Calogero",
            "initials": "C",
            "lastname": "Vetro"
        },
        {
            "affiliation": "Division of Hematology, BMT Unit, AOU Policlinico G Rodolico S Marco, Catania, Italy.",
            "firstname": "Salvatore",
            "initials": "S",
            "lastname": "Leotta"
        },
        {
            "affiliation": "Department of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.",
            "firstname": "Valentina",
            "initials": "V",
            "lastname": "Mancini"
        },
        {
            "affiliation": "Department of Hematology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.",
            "firstname": "Elisabetta",
            "initials": "E",
            "lastname": "Terruzzi"
        },
        {
            "affiliation": "Unit of Hematology and Bone Marrow Transplantation, IRCCS Ospedale San Raffaele, Milan, Italy.",
            "firstname": "Massimo",
            "initials": "M",
            "lastname": "Bernardi"
        },
        {
            "affiliation": "UOC Hematology, Mazzoni Hospital Ascoli Piceno, Ascoli Piceno, Italy.",
            "firstname": "Piero",
            "initials": "P",
            "lastname": "Galieni"
        },
        {
            "affiliation": "UOC Ematologia, Bari, Italy.",
            "firstname": "Pellegrino",
            "initials": "P",
            "lastname": "Musto"
        },
        {
            "affiliation": "Department of Hematology, Stem Cell Transplant Unit, Policlinico Tor Vergata, Rome, Italy.",
            "firstname": "Raffaella",
            "initials": "R",
            "lastname": "Cerretti"
        },
        {
            "affiliation": "Univesity of Torino, AOU Citt\u00e0 Della Salute E Della Scienza Di Torino, Torino, Italy.",
            "firstname": "Luisa",
            "initials": "L",
            "lastname": "Giaccone"
        },
        {
            "affiliation": "Unit of Haematology and Bone Marrow Transplantation, Ospedale Dell'Angelo, Venezia Mestre, Italy.",
            "firstname": "Cristina",
            "initials": "C",
            "lastname": "Skert"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Vera",
            "initials": "V",
            "lastname": "Radici"
        },
        {
            "affiliation": "Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.",
            "firstname": "Marika",
            "initials": "M",
            "lastname": "Vezzoli"
        },
        {
            "affiliation": "Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.",
            "firstname": "Stefano",
            "initials": "S",
            "lastname": "Calza"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy; Centro di Ricerca Emato-Oncologica AIL, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Alessandro",
            "initials": "A",
            "lastname": "Leoni"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy; Centro di Ricerca Emato-Oncologica AIL, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Luca",
            "initials": "L",
            "lastname": "Garuffo"
        },
        {
            "affiliation": "Molecular Markers Laboratory, IRCCS Istituto Centro San Giovanni Di Dio Fatebenefratelli, Brescia, Italy.",
            "firstname": "Cristian",
            "initials": "C",
            "lastname": "Bonvicini"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Simone",
            "initials": "S",
            "lastname": "Pellizzeri"
        },
        {
            "affiliation": "Department of Clinical and Experimental Science, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.",
            "firstname": "Michele",
            "initials": "M",
            "lastname": "Malagola"
        },
        {
            "affiliation": "Unit of Hematology and Stem Cell Transplantation, Ospedale San Raffaele, University Vita-Salute San Raffaele, Milan, Italy.",
            "firstname": "Fabio",
            "initials": "F",
            "lastname": "Ciceri"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2024 The Author(s). Published by Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.",
    "doi": "10.1016/S2352-3026(24)00241-2",
    "journal": "The Lancet. Haematology",
    "keywords": [],
    "methods": null,
    "publication_date": "2024-09-24",
    "pubmed_id": "39312920",
    "results": null,
    "title": "Venetoclax plus decitabine as a bridge to allogeneic haematopoietic stem-cell transplantation in older patients with acute myeloid leukaemia (VEN-DEC GITMO): final report of a multicentre, single-arm, phase 2 trial.",
    "xml": "<Element 'PubmedArticle' at 0x788507014720>"
}