VINCENT: A randomized-controlled trial evaluating venetoclax plus azacitidine versus intensive chemotherapy in patients with newly diagnosed, NPM1-mutated AML
Annals of Hematology, vol. 104, pp. 3647–3654
Abstract
Abstract For younger, medically fit patients with NPM1-mutated, FLT3-wildtype acute myeloid leukemia (AML) intensive chemotherapy represents standard of care (SOC), with complete remission (CR) rates observed in up to 85% of patients and 5-year overall survival (OS) rates of 40–50%. However, significant toxicity and need for hospitalization pose challenges on patients’ outcome and quality of life (QoL). Venetoclax (VEN) combined with azacitidine (AZA) has demonstrated encouraging efficacy in older, unfit AML patients, achieving high CR/CRi rates and promising OS with lower toxicity. Prospective, randomized data comparing VEN/AZA to SOC in younger, fit patients are currently missing. VINCENT is a randomized-controlled, multicenter, non-inferiority, phase 2 trial (NCT05904106) evaluating VEN/AZA versus SOC in adults aged 18–70 years with newly diagnosed, NPM1-mutated, FLT3-wildtype AML. Patients medically fit for intensive chemotherapy (ECOG ≤ 2) with adequate organ function are eligible, while patients with relapsed/refractory AML or prior cytotoxic treatment are excluded. A total of 146 patients will be randomized 1:1 to receive either VEN/AZA or SOC. Hematologic remission is evaluated according to ELN 2022 guidelines. The primary endpoint is the modified event-free survival, defined as either primary induction failure, hematologic relapse, molecular failure or death. Secondary endpoints include safety, tolerability, CR/CRi/CRh/CRMRD− rates, MRD kinetics (using NPM1 RT-qPCR and MFC), relapse-free survival, OS, early mortality, health-related QoL and cumulative health-care-resource use. Patients will be followed up for at least two years post enrollment. The VINCENT trial will be the first study to provide comprehensive prospective data comparing VEN/AZA to SOC, addressing both efficacy and patient-centered outcomes.
Authors 39
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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Affiliation as printed
Department of Medicine A, University Hospital Münster, Münster, Germany
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University Hospital Schleswig-Holstein
Affiliation as printed
Department of Hematology and Oncology, University Hospital Schleswig- Holstein, Campus Kiel, Kiel, Germany
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Affiliation as printed
Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany
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Affiliation as printed
Robert Bosch Hospital, Stuttgart, Germany
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Universitätsklinikum Gießen und Marburg
Affiliation as printed
Department of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Marburg, Marburg, Germany
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Affiliation as printed
Department of Internal Medicine II, Hematology and Oncology, University Hospital Augsburg, Augsburg, Germany
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Essen University Hospital · University of Duisburg-Essen
Affiliation as printed
Department of Hematology and Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
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Affiliation as printed
Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany
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University Hospital Leipzig · Leipzig University
Affiliation as printed
Department of Internal Medicine I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany
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Nuremberg Hospital · Paracelsus Medizinische Privatuniversität
Affiliation as printed
Department of Internal Medicine V, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany
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Affiliation as printed
Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany
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Martina Margrit Crysandt Aachen Department of Hematology, Oncology Medical Faculty Center for Integrated Oncology Aachen
Affiliation as printed
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen, Bonn Cologne Duesseldorf, Aachen, Germany
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Düsseldorf University Hospital
Affiliation as printed
University Hospital of Düsseldorf, Düsseldorf, Germany
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Affiliation as printed
Department of Internal Medicine V, University Hospital Erlangen, Erlangen, Germany
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Affiliation as printed
University Hospital Halle, Halle, Germany
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University Medical Centre Mannheim
Affiliation as printed
University Medical Centre Mannheim, Mannheim, Germany
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University of Cologne · University Hospital Cologne
Affiliation as printed
Department I of Internal Medicine, Faculty of Medicine and Cologne University Hospital, Center for Integrated Oncology Aachen, University of Cologne, Bonn, Cologne, Düsseldorf, Cologne, Germany
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LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
LMU Hospital, Munich, Germany
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Helios Dr. Horst Schmidt Kliniken Wiesbaden
Affiliation as printed
Department of Internal Medicine III, Hematology, Oncology and Palliative Care, Helios Dr. Horst Schmidt Hospital Wiesbaden, Wiesbaden, Germany
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Affiliation as printed
Department of Hematology, Oncology and Immunology, St. Bernward Hospital, Hildesheim, Germany
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Affiliation as printed
University Hospital OWL/Bielefeld Hospital, Bielefeld, Germany
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Affiliation as printed
Department of Internal Medicine III, Hematology and Oncology, Rotkreuzklinikum München, Munich, Germany
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Sozialstiftung Bamberg · Comprehensive Cancer Center Erlangen
Affiliation as printed
Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany
Department of Internal Medicine V, Sozialstiftung Bamberg, Bamberg, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
AgenDix GmbH, Dresden, Germany
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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Affiliation as printed
King's College, London, UK
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University Hospital Schleswig-Holstein
Affiliation as printed
Department of Hematology and Oncology, University Hospital Schleswig- Holstein, Campus Kiel, Kiel, Germany
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Affiliation as printed
Department of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany
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LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
LMU Hospital, Munich, Germany
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LMU Klinikum · Ludwig-Maximilians-Universität München
Affiliation as printed
LMU Hospital, Munich, Germany
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Affiliation as printed
Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany
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Affiliation as printed
Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany
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