Evidence map›Paper›PMID 41026969›Full record

Trial reportBlood advances2025

Safety and efficacy of combining midostaurin and gemtuzumab ozogamicin with induction chemotherapy in FLT3-mutated AML.

Nigel Russell, Jad Othman, Oliver Cumming, Abin Thomas, Aditya Tedjaseputra, Nicola Potter, Jelena Jovanovic, Amanda Gilkes, Leona Batten, Joanna Canham and 10 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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

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

  1. Pooled it
  2. Review
  3. Article
  4. Cancers · 2026
    Review
  5. Article
  6. 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

20 authors.

Nigel RussellDepartment of Clinical Haematology, Guy's and St Thomas' Hospitals NHS Trust, London, United Kingdom.
Jad OthmanDepartment of Medical and Molecular Genetics, King's College, London, United Kingdom.ORCID 0000-0002-4971-3576
Oliver CummingCentre for Trials Research, Cardiff University, Cardiff, United Kingdom.
Abin ThomasCentre for Trials Research, Cardiff University, Cardiff, United Kingdom.ORCID 0000-0002-8283-6762
Aditya TedjaseputraDepartment of Clinical Haematology, Guy's and St Thomas' Hospitals NHS Trust, London, United Kingdom.ORCID 0000-0001-6224-1940
Nicola PotterDepartment of Medical and Molecular Genetics, King's College, London, United Kingdom.ORCID 0000-0002-8256-9350
Jelena JovanovicDepartment of Medical and Molecular Genetics, King's College, London, United Kingdom.
Amanda GilkesDepartment of Haematology, School of Medicine, Cardiff University, Cardiff, United Kingdom.
Leona BattenCentre for Trials Research, Cardiff University, Cardiff, United Kingdom.ORCID 0000-0002-0441-0459
Joanna CanhamCentre for Trials Research, Cardiff University, Cardiff, United Kingdom.ORCID 0000-0003-3482-0990
Emily HinsonCentre for Trials Research, Cardiff University, Cardiff, United Kingdom.
Manohursingh RunglallDepartment of Medical and Molecular Genetics, King's College, London, United Kingdom.
Phoebe AuckenDepartment of Medical and Molecular Genetics, King's College, London, United Kingdom.
Panos KottaridisDepartment of Haematology, University College London Hospitals NHS Trust, London, United Kingdom.
Jamie CavenaghDepartment of Haematology, Bart's and the London Hospitals NHS Trust, London, United Kingdom.
Claire ArnoldDepartment of Haematology, Belfast City Hospital, Belfast, United Kingdom.
Sylvie FreemanClinical Immunology Service, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom.ORCID 0000-0003-1869-180X
Mike DennisDepartment of Haematology, The Christie Hospital NHS Trust, Manchester, United Kingdom.ORCID 0000-0002-2540-8673
Steven KnapperDepartment of Haematology, School of Medicine, Cardiff University, Cardiff, United Kingdom.ORCID 0000-0002-6405-4441
Richard DillonDepartment of Clinical Haematology, Guy's and St Thomas' Hospitals NHS Trust, London, United Kingdom.ORCID 0000-0001-9333-5296

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractDespite the use of FMS-like tyrosine kinase 3 (FLT3) inhibitors, outcomes for patients with FLT3-mutated (FLT3mut) acute myeloid leukemia (AML) remain suboptimal because of high rates of relapse. We evaluated the safety and efficacy of the combination of daunorubicin, cytarabine (DA), gemtuzumab ozogamicin (GO), and midostaurin (DAGO+m) for younger patients with newly diagnosed FLT3mut AML in the UK National Cancer Research Institute AML19 trial. A total of 195 patients were randomized to receive DA with either 1 or 2 doses of GO (DAGO1 and DAGO2). Overall, 77 had an FLT3 mutation and received midostaurin for 2 weeks after each chemotherapy course and then as maintenance for 1 year unless they received a transplant. A total of 39 patients received DAGO1+m and 38 DAGO2+m. Their median age was 51 years (range, 20-74), and 16 (20%) were aged >60 years. The overall response rate was 91%. Day 60 mortality was 0%, with no increase in toxicity compared with patients treated contemporaneously with DAGO1 and DAGO2 without midostaurin. Two-year overall survival was 77%. Two-year event-free survival and cumulative incidence of relapse were 62% and 31%, respectively. Measurable residual disease (MRD) clearance was enhanced compared with patients with FLT3mut AML treated with DAGO without midostaurin. Overall, 81% of evaluable patients were NPM1 MRD negative in the peripheral blood after course 2 (76% with DAGO1+m, and 86% with DAGO2+m), 79% were MRD negative in the bone marrow by FLT3-ITD next-generation sequencing, and all patients had FLT3-MRD levels <0.01%. DAGO+m appears safe and effective. DAGO2+m will now be evaluated in a randomized study. This trial was registered at www.isrctn.com as #ISRCTN78449203.

Indexed as

Antineoplastic Combined Chemotherapy Protocolsfms-Like Tyrosine Kinase 3GemtuzumabInduction ChemotherapyLeukemia, Myeloid, AcuteMutationStaurosporineAdultAgedFemaleHumansMaleMiddle AgedNucleophosminTreatment OutcomeYoung AdultFLT3 protein, humanfms-Like Tyrosine Kinase 3GemtuzumabmidostaurinNPM1 protein, humanNucleophosminStaurosporine

Identifiers

PMID41026969
PMCPMC12757529

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Registered trials

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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.