Evidence map›Paper›PMID 40629154›Full record

ArticleAnnals of hematology2025

VINCENT: A randomized-controlled trial evaluating venetoclax plus azacitidine versus intensive chemotherapy in patients with newly diagnosed, NPM1-mutated AML.

Lydia Kretschmer, Leo Ruhnke, Christoph Schliemann, Lars Fransecky, Björn Steffen, Martin Kaufmann, Andreas Burchert, Christoph Schmid, Maher Hanoun, Tim Sauer and 31 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05904106 (Venetoclax Plus Azacitidine Versus Standard Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05904106 phase2recruitingnot on this map

Venetoclax Plus Azacitidine Versus Standard Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and NPM1 Mutations Eligible for Intensive Treatment

TypeinterventionalSponsorTechnische Universität DresdenRan2024 to 2030Enrolled146ConditionsAcute Myeloid LeukemiaArmsVenetoclax plus Azacitidine, standard of care chemotherapy plus gemtuzumab ozogamicin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

41 authors.

Lydia Kretschmer *Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany. lydia.kretschmer@ukdd.de.
Leo Ruhnke *Department of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Christoph SchliemannDepartment of Medicine A, University Hospital Münster, Münster, Germany.
Lars FranseckyDepartment of Hematology and Oncology, University Hospital Schleswig- Holstein, Campus Kiel, Kiel, Germany.
Björn SteffenDepartment of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany.
Martin KaufmannRobert Bosch Hospital, Stuttgart, Germany.
Andreas BurchertDepartment of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Marburg, Marburg, Germany.
Christoph SchmidDepartment of Internal Medicine II, Hematology and Oncology, University Hospital Augsburg, Augsburg, Germany.
Maher HanounDepartment of Hematology and Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Tim SauerDepartment of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
Klaus H MetzelerDepartment of Internal Medicine I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany.
Kerstin Schäfer-EckartDepartment of Internal Medicine V, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
Mathias HänelDepartment of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.
Martina CrysandtDepartment of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen, Bonn Cologne Duesseldorf, Aachen, Germany.
Paul JägerUniversity Hospital of Düsseldorf, Düsseldorf, Germany.
Stefan W KrauseDepartment of Internal Medicine V, University Hospital Erlangen, Erlangen, Germany.
Christine DierksUniversity Hospital Halle, Halle, Germany.
Stefan KleinUniversity Medical Centre Mannheim, Mannheim, Germany.
Nadia MaguireBarmherzige Brüder Hospital, Regensburg, Germany.
Lukas P FrenzelDepartment I of Internal Medicine, Faculty of Medicine and Cologne University Hospital, Center for Integrated Oncology Aachen, University of Cologne, Bonn, Cologne, Düsseldorf, Cologne, Germany.
Veit L BückleinLMU Hospital, Munich, Germany.
Wolfgang BlauDepartment of Internal Medicine III, Hematology, Oncology and Palliative Care, Helios Dr. Horst Schmidt Hospital Wiesbaden, Wiesbaden, Germany.
Ulrich KaiserDepartment of Hematology, Oncology and Immunology, St. Bernward Hospital, Hildesheim, Germany.
Kai WegehenkelUniversity Hospital OWL/Bielefeld Hospital, Bielefeld, Germany.
Alexander HölleinDepartment of Internal Medicine III, Hematology and Oncology, Rotkreuzklinikum München, Munich, Germany.
Ruth Seggewiss-BernhardtDepartment of Internal Medicine V, Sozialstiftung Bamberg, Bamberg, Germany.
Wenke MarkgrafDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Frank FiebigDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Anna HarigDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Katharina Schmidt-BrückenDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Christian ThiedeDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Jan Moritz MiddekeDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Richard DillonKing's College, London, UK.
Claudia D BaldusDepartment of Hematology and Oncology, University Hospital Schleswig- Holstein, Campus Kiel, Kiel, Germany.
Hubert ServeDepartment of Internal Medicine II, University Hospital Frankfurt, Frankfurt, Germany.
Karsten SpiekermannLMU Hospital, Munich, Germany.
Wolfgang HiddemannLMU Hospital, Munich, Germany.
Richard F SchlenkDepartment of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
Carsten Müller-TidowDepartment of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
Martin BornhäuserDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.
Christoph RölligDepartment of Internal Medicine I, University Hospital Dresden, TU Dresden, Fetscherstraße 74, Dresden, 01307, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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/CR

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAzacitidineBridged Bicyclo Compounds, HeterocyclicLeukemia, Myeloid, AcuteMutationNuclear ProteinsSulfonamidesAdolescentAdultAgedClinical Trials, Phase II as TopicEquivalence Trials as TopicFemaleHumansMaleMiddle AgedAzacitidineBridged Bicyclo Compounds, HeterocyclicNPM1 protein, humanNuclear ProteinsNucleophosminSulfonamidesvenetoclaxAMLAzacitidineFit patientsIntensive chemotherapyNPM1Venetoclax

Identifiers

PMID40629154
PMCPMC12334493

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.