Evidence map›Paper›PMID 40913104›Full record

Trial reportLeukemia2025

Outcomes of patients treated with venetoclax plus azacitidine versus azacitidine alone stratified by advanced age and acute myeloid leukemia composite model.

Adriano Venditti, Jing-Zhou Hou, Pierre Fenaux, Brian A Jonas, Radovan Vrhovac, Pau Montesinos, Jacqueline S Garcia, David Rizzieri, Michael J Thirman, Meng Zhang and 4 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Review
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  5. Review
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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

14 authors.

Adriano VendittiHematology, Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy. adriano.venditti@uniroma2.it.ORCID 0000-0002-0245-0553
Jing-Zhou HouHematology and BMT, Lemieux Center for Blood Cancers, UPMC Hillman Cancer Center, Pittsburgh, PA, USA.ORCID 0000-0001-8916-0921
Pierre FenauxHôpital St. Louis/Assistance Publique‑Hôpitaux de Paris and Université de Paris, Paris, France.
Brian A JonasDepartment of Internal Medicine, Division of Malignant Hematology, Cellular Therapy and Transplantation, University of California Davis School of Medicine, Sacramento, CA, USA.ORCID 0000-0002-4921-5809
Radovan VrhovacDepartment of Haematology, University Hospital Centre Zagreb, and University of Zagreb School of Medicine, Zagreb, Croatia.ORCID 0000-0003-3323-3487
Pau MontesinosHospital Universitari i Politecnic la Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
Jacqueline S GarciaDepartment of Medical Oncology, Dana‑Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-2118-6302
David RizzieriNovant Health Cancer Institute, Winston Salem, NC, USA.
Michael J ThirmanDepartment of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
Meng ZhangAbbVie Inc., North Chicago, IL, USA.
Jalaja PotluriAbbVie Inc., North Chicago, IL, USA.
Catherine MillerAbbVie Inc., North Chicago, IL, USA.
Mazaher DhallaAbbVie Inc., North Chicago, IL, USA.
Vinod PullarkatDepartment of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.ORCID 0000-0001-9129-3424

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Venetoclax plus azacitidine is recognized as standard of care for patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC). However, some patients may still not be treated with venetoclax combinations due to frailty concerns. We evaluated efficacy and safety of venetoclax plus azacitidine vs. placebo plus azacitidine in patients with newly diagnosed AML ineligible for IC from the phase 3 VIALE-A study (NCT02993523) and the phase 1b M14-358 study (NCT02203773), stratified by two methods to potentially assess frailty. The first method was age-based (75-79, 80-84, ≥85 years; n = 303 pooled from both studies) and the second was fitness-based using the AML composite model (AML-CM), a comorbidity-based model to estimate mortality risk (Group A, B, C; n = 380, from VIALE-A). Efficacy, including composite complete remission and overall survival, were improved with venetoclax plus azacitidine vs. placebo plus azacitidine across age and AML-CM groups. Safety was generally similar between age and AML-CM groups and no new safety signals were identified. Taken together, these data suggest that patients benefit from venetoclax plus azacitidine regardless of age or degree of frailty and the combination may be considered for patients with AML who may be deemed frail. Clinical trial information NCT02993523; NCT02203773.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAzacitidineLeukemia, Myeloid, AcuteAgedAged, 80 and overAge FactorsBridged Bicyclo Compounds, HeterocyclicFemaleHumansMalePrognosisSulfonamidesSurvival RateTreatment OutcomeAzacitidineBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclax

Identifiers

PMID40913104
PMCPMC12589120

What Socratic holds

Textmetadata
LicenceCC BY
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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.