Evidence map›Paper›PMID 36376888›Full record

ArticleBMC cancer2022

Venetoclax combined with low dose cytarabine compared to standard of care intensive chemotherapy for the treatment of favourable risk adult acute myeloid leukaemia (VICTOR): Study protocol for an international, open-label, multicentre, molecularly-guided randomised, phase II trial.

Richard Dillon, Shanna Maycock, Aimee Jackson, Sonia Fox, Sylvie Freeman, Charles Craddock, Catherine Thomas, Emma Homer, Jane Leahy, Anna Mamwell and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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

17 authors at 9 institutions in 4 countries.

Richard DillonDepartment of Medical and Molecular Genetics, King's College London, London, UK. richard.dillon@kcl.ac.uk.ORCID http://orcid.org/0000-0001-9333-5296
Shanna MaycockCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Aimee JacksonCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Sonia FoxCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Sylvie FreemanClinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Charles CraddockCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Catherine ThomasCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Emma HomerCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Jane LeahyBlood Cancer UK, London, UK.
Anna MamwellBlood Cancer UK, London, UK.
Nicola PotterDepartment of Medical and Molecular Genetics, King's College London, London, UK.
Nigel RussellSchool of Medicine, Clinical Sciences Building, The University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham, NG5 1PB, UK.
Andrew WeiPeter MacCallum Cancer Centre, 305 Grattan Street, Melbourne. VIC 3000, Australia.
Hans Beier OmmenDepartment of Hematology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus C, Denmark.
Claire HemmawayDepartment of Haematology, Auckland City Hospital, Auckland, New Zealand.
Steve KnapperInstitute of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, CF14 4XN, UK.
Lucinda BillinghamCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Cancer Research UK Clinical Trials Unit · GBBlood Cancer UK · GBKing's College London · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBAarhus University Hospital · DKAuckland City Hospital · NZCardiff University · GBPeter MacCallum Cancer Centre · AUUniversity of Nottingham · GB

Funding

Cancer Research UK 25354Cancer Research UK 29806Cancer Research UK C65869/A29806
6 · The paper itself

Abstract

backgroundFor patients with acute myeloid leukaemia (AML), the only potentially curative treatment is intensive chemotherapy (IC). This is highly toxic, particularly for patients > 60 years, potentially leading to prolonged hospitalisations requiring intensive supportive care, and sometimes treatment-related death. This also results in extensive healthcare costs and negatively impacts quality of life (QoL). Venetoclax with low-dose cytarabine (VEN + LDAC) is a novel, low-intensity treatment for AML patients who cannot receive IC. VEN + LDAC is given as an outpatient and toxicity appears significantly lower than with IC. Analysis of clinical trials performed to date are promising for patients with the genotype NPM1

methodsVICTOR is an international, two-arm, open-label, multi-centre, non-inferiority, randomised-controlled phase II trial to assess VEN + LDAC compared to standard of care (IC) as first-line treatment in older patients (initially aged ≥ 60 years) with newly diagnosed AML. The trial will recruit patients with a NPM1 DISCUSSION: The principle underpinning the VICTOR trial is that the chance of cure for patients in the experimental arm should not be compromised, therefore, an adaptive design with regular checks on accumulating data has been employed, which will allow for a staged expansion of the trial population to include younger patients if, and when, there is sufficient evidence of non-inferiority in older patients.

trial registrationEudraCT: 2020-000,273-24; 21-Aug-2020. ISRCTN: 15,567,173; 08-Dec-2020.

Indexed as

Antineoplastic AgentsLeukemia, Myeloid, AcuteAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBayes TheoremBridged Bicyclo Compounds, HeterocyclicClinical Trials, Phase II as TopicCytarabineEquivalence Trials as TopicHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalNuclear ProteinsQuality of LifeStandard of CareAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicCytarabineNuclear ProteinsSulfonamidesvenetoclaxAcute myeloid leukaemiaAdaptive designBayesian non-inferiority designClinical trialLow-dose cytarabineVenetoclax

Identifiers

PMID36376888
PMCPMC9664612
OpenAlexW4308995518

What OpenQuestion holds

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Registered trials

None linked

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.