Evidence map›Paper›PMID 39133921›Full record

ArticleBlood2024

Genetic risk stratification and outcomes among treatment-naive patients with AML treated with venetoclax and azacitidine.

Hartmut Döhner, Keith W Pratz, Courtney D DiNardo, Andrew H Wei, Brian A Jonas, Vinod A Pullarkat, Michael J Thirman, Christian Récher, Andre C Schuh, Sunil Babu and 8 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Blood, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 110 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 1 pooled it
–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.

NCT02203773 phase1terminatednot on this map

A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy

TypeinterventionalSponsorAbbVieRan2014 to 2022Enrolled212ConditionsAcute Myelogenous Leukemia, Myelogenous Leukemia, Treatment Naive AMLArmsPosaconazole, ABT-199, Decitabine, Azacitidine
NCT02993523 phase3active not recruitingnot on this map

A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

TypeinterventionalSponsorAbbVieRan2017 to 2026Enrolled443ConditionsAcute Myeloid Leukemia (AML)ArmsAzacitidine, Venetoclax, Placebo
NCT07511062 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients

TypeinterventionalSponsorNorthside Hospital, Inc.Ran2026 to 2030Enrolled32ConditionsAcute Myeloid Leukemia, TP53 Gene MutationArmsDecitabine, Venetoclax, Axatilimab
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  9. Azacitidine, Venetoclax, and Magrolimab in Newly Diagnosed and Relapsed Refractory Acute Myeloid Leukemia: Phase Ib/II Study and Correlative Analysis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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  19. Risk Prognostication After Hypomethylating Agents Combined With Venetoclax in AML: The PRISM Risk Model.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
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50 more citing papers are in PubMed but not listed here.

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

18 authors.

Hartmut DöhnerDepartment of Internal Medicine III, Ulm University Hospital, Ulm, Germany.ORCID 0000-0003-2116-5536
Keith W PratzDivision of Hematology-Oncology, Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9003-0390
Andrew H WeiDepartment of Clinical Haematology, Peter MacCallum Cancer Centre, The Royal Melbourne Hospital, Walter and Eliza Hall Institute of Medical Research and The University of Melbourne, Melbourne, Australia.ORCID 0000-0002-7514-3298
Brian A JonasDivision of Malignant Hematology/Cellular Therapy and Transplantation, Department of Internal Medicine, University of California Davis School of Medicine, Sacramento, CA.ORCID 0000-0002-4921-5809
Vinod A PullarkatDepartment of Hematology and Hematopoietic Cell Transplantation, City of Hope Comprehensive Cancer Center, Duarte, CA.
Michael J ThirmanDepartment of Medicine, Section of Hematology and Oncology, University of Chicago Medicine, Chicago, IL.
Christian RécherService d'Hématologie, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France.ORCID 0000-0002-3332-4525
Andre C SchuhDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Canada.
Sunil BabuDivision of Clinical Research, Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN.
Xiaotong LiAbbVie Inc, North Chicago, IL.
Grace KuGenentech Inc, South San Francisco, CA.
Zihuan LiuAbbVie Inc, North Chicago, IL.
Yan SunAbbVie Inc, North Chicago, IL.ORCID 0000-0001-7856-7195
Jalaja PotluriAbbVie Inc, North Chicago, IL.
Monique DailGenentech Inc, South San Francisco, CA.
Brenda ChylaAbbVie Inc, North Chicago, IL.
Daniel A PollyeaDivision of Hematology, School of Medicine, University of Colorado, Aurora, CO.ORCID 0000-0001-6519-4860

Funding

NCI R50 Clinician Scientist AwardR50CA276013 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Brian A. Jonas · 2023 to 2026
$349k
NCI NIH HHS R50 CA276013
6 · The paper itself

Abstract

abstractThe European LeukemiaNet (ELN) acute myeloid leukemia (AML) genetic risk classification systems are based on response to intensive chemotherapy; their ability to discriminate outcomes in older patients treated with venetoclax-azacitidine may be suboptimal. This pooled analysis of the phase 3 VIALE-A trial (NCT02993523) and phase 1b study (NCT02203773) examined prognostic stratification according to the 2017 and 2022 ELN risk classifications and derived new molecular signatures differentiating venetoclax-azacitidine-treated patients based on overall survival (OS). Overall, 279 patients treated with venetoclax-azacitidine and 113 patients treated with placebo-azacitidine were analyzed. The ELN 2017 or 2022 prognostic criteria classified most patients as adverse-risk AML (60.2% and 72.8% for venetoclax-azacitidine and 65.5% and 75.2% for placebo-azacitidine, respectively). Although outcomes with venetoclax-azacitidine improved across all ELN risk groups compared with placebo-azacitidine, ELN classification systems poorly discriminated venetoclax-azacitidine outcomes. By applying a bioinformatic algorithm, new molecular signatures were derived differentiating OS outcomes with venetoclax-azacitidine. The mutational status of TP53, FLT3 internal tandem duplication (FLT3-ITD), NRAS, and KRAS categorized patients into higher-, intermediate-, and lower-benefit groups (52%, 25%, and 23% of patients, respectively), each associated with a distinct median OS (26.5 months [95% confidence interval (CI), 20.2-32.7]; 12.1 months [95% CI, 7.3-15.2]; and 5.5 months [95% CI, 2.8-7.6], respectively). ELN prognostic classifiers did not provide clinically meaningful risk stratification of OS outcomes in patients treated with venetoclax-azacitidine. TP53, FLT3-ITD, NRAS, and KRAS mutation status allows the classification of these patients into 3 risk groups with distinct differences in median OS. These trials were registered at www.clinicaltrials.gov as #NCT02993523 and #NCT02203773.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAzacitidineBridged Bicyclo Compounds, HeterocyclicLeukemia, Myeloid, AcuteSulfonamidesAdultAgedAged, 80 and overClinical Trials, Phase I as TopicClinical Trials, Phase III as TopicFemaleHumansMaleMiddle AgedMutationPrognosisAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclax

Identifiers

PMID39133921
PMCPMC11600046

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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 OpenQuestion graph.