Evidence map›Paper›PMID 41269778›Full record

ArticleBlood advances2026

Risk stratification of low-dose cytarabine and venetoclax in patients with AML ineligible for intensive chemotherapy.

Andrew H Wei, Panayiotis Panayiotidis, Pau Montesinos, Kamel Laribi, Vladimir Ivanov, Inho Kim, Jan Novak, Rebecca Champion, Walter Fiedler, Maria Pagoni and 19 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Blood advances, 2026. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02287233 phase1 / phase2completednot on this map

A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

TypeinterventionalSponsorAbbVieRan2014 to 2021Enrolled94ConditionsAcute Myelogenous Leukemia, AMLArmsVenetoclax, Cytarabine
NCT03069352 phase3completednot on this map

A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

TypeinterventionalSponsorAbbVieRan2017 to 2025Enrolled211ConditionsAcute Myeloid Leukemia (AML)ArmsPlacebo, Venetoclax, Cytarabine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

29 authors.

Andrew H WeiDepartment of Clinical Haematology, Peter MacCallum Cancer Centre, The Royal Melbourne Hospital and Division of Blood Cells and Blood Cancers, The Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia.ORCID 0000-0002-7514-3298
Panayiotis PanayiotidisDepartment of Haematology and Bone Marrow Transplantation Unit, Laiko General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.ORCID 0000-0003-0387-3993
Pau MontesinosDepartment of Hematology, Hospital Universitario y Politécnico La Fe, Valencia, Spain and CIBERONC, Instituto Carlos III, Madrid, Spain.ORCID 0000-0002-3275-5593
Kamel LaribiDepartment of Hematology, Centre Hospitalier-Le Mans, Le Mans, France.
Vladimir IvanovDepartment of Internal Medicine at the Institute of Medical Education, Almazov National Medical Research Center, Saint Petersburg, Russia.ORCID 0000-0003-1536-9313
Inho KimDepartment of Hematology-Oncology, Seoul National University Hospital, Seoul, Korea.
Jan NovakDepartment of Internal Medicine and Hematology, University Hospital Královské Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic.
Rebecca ChampionNorton Cancer Institute, Louisville, KY.
Walter FiedlerDepartment of Oncology, Hematology and Bone Marrow Transplantation with Section Pneumology, Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Maria PagoniHematology-Lymphomas Department - BMT Unit, Evangelismos General Hospital, Athens, Greece.
Julie BergeronCIUSSS-EMTL, Installation Maisonneuve-Rosemont, Montreal, QC, Canada.
Stephen B TingDepartment of Haematology, Eastern Health and Monash University, Melbourne, VIC, Australia.ORCID 0000-0001-7755-8326
Jing-Zhou HouDepartment of Hematology Oncology, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA.
Takahiro YamauchiDepartment of Hematology and Oncology, University of Fukui Hospital, Fukui, Japan.
Jianxiang WangInstitute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.ORCID 0000-0001-9437-9151
Stephen A StricklandDivision of Hematologic Oncology, SCRI at TriStar Centennial Medical Center, Nashville, TN.ORCID 0000-0002-6861-2041
Michael R SavonaDepartment of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN.ORCID 0000-0003-3763-5504
Tara L LinDivision of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS.ORCID 0000-0002-0242-6449
Anoop EnjetiDepartment of Hematology, Calvary Mater Hospital Newcastle, Waratah, NSW, Australia.
Ing Soo TiongDepartment of Pathology, Peter MacCallum Cancer Centre and The Royal Melbourne Hospital, Melbourne, VIC, Australia.ORCID 0000-0001-7417-4343
Sangmin LeeDivision of Hematology and Oncology, Weill Cornell Medical College, New York, NY.
Gail J RobozDivision of Hematology and Oncology, Weill Cornell Medical College, New York, NY.ORCID 0000-0002-0384-3658
Relja PopovicAbbVie Inc, North Chicago, IL.
Qi JiangAbbVie Inc, North Chicago, IL.
Zihuan LiuAbbVie Inc, North Chicago, IL.
Yan SunAbbVie Inc, North Chicago, IL.ORCID 0000-0001-7856-7195
Wellington MendesAbbVie Inc, North Chicago, IL.
Brenda ChylaAbbVie Inc, North Chicago, IL.
Courtney D DiNardoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9003-0390

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractPrognostic risk categorization aids treatment selection for patients with acute myeloid leukemia (AML). Although the European LeukemiaNet (ELN) classifications (2017 and 2022) for AML have been used to stratify outcomes for patients receiving intensive chemotherapy, their application to patients receiving less intensive therapy, such as azacitidine plus venetoclax, has been less satisfactory. In response, a 4-gene classifier that stratifies older patients with AML unfit for intensive chemotherapy into those with higher benefit (wild type), intermediate benefit (FLT3-internal tandem duplication [ITD] or NRAS/KRAS mutation), or lower benefit (TP53 mutation) after azacitidine plus venetoclax treatment was developed. We hypothesized that this 4-gene classifier may also have prognostic utility in patients receiving low-dose cytarabine (LDAC) plus venetoclax. Surprisingly, neither the ELN 2022 criteria nor the 4-gene azacitidine-venetoclax classifier model adequately stratified prognosis in a cohort of 139 patients receiving LDAC plus venetoclax. Patients with concurrent NPM1 and FLT3-ITD/RAS variants performed surprisingly well with LDAC plus venetoclax (complete remission [CR]/CR with incomplete blood count recovery [CRi] rate, 92%; median overall survival [OS], 29.67 months). Data-driven (sequential bootstrapping and tree-based) and empirical analyses identified complex karyotype and/or presence of TP53 mutation as prognostically relevant molecular/cytogenetic risk markers. Patients with complex karyotype and/or TP53 mutation displayed poor clinical outcomes (CR/CRi, 25%; median OS, 3.48 months). Notably, 74% of the study population lacked these poor prognostic markers and had a 67% CR/CRi rate with a median OS of 14.92 months. Overall, these data support the importance of molecular subclassification in defining treatment outcomes to venetoclax-based therapies. These trials were registered at www.clinicaltrials.gov as #NCT02287233 and #NCT03069352.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicCytarabineLeukemia, Myeloid, AcuteSulfonamidesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedMutationNucleophosminPrognosisRisk AssessmentBridged Bicyclo Compounds, HeterocyclicCytarabineNPM1 protein, humanNucleophosminSulfonamidesvenetoclax

Identifiers

PMID41269778
PMCPMC12914422

What OpenQuestion 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 OpenQuestion graph.