Evidence map›Paper›PMID 37604981›Full record

Trial reportLeukemia2023

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial.

Mikkael A Sekeres, Pau Montesinos, Jan Novak, Jianxiang Wang, Deepa Jeyakumar, Benjamin Tomlinson, Jiri Mayer, Erin Jou, Tadeusz Robak, David C Taussig and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Leukemia, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03416179 (A RANDOMIZED), which is not on this map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT03416179 phase3completednot on this map

A randomized (1:1), double-blind, multi-center, placebo controlled study evaluating intensive chemotherapy with or without glasdegib (pf-04449913) or azacitidine (aza) with or without glasdegib in patients with previously untreated acute myeloid leukemia

TypeinterventionalSponsorPfizerRan2018 to 2022Enrolled730ConditionsLeukemia, Myeloid, AcuteArmsglasdegib, daunorubicin + cytarabine, azacitidine, Placebo, cytarabine
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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  16. Molecularly targeted therapy and immunotherapy in leukemias.Journal of hematology & oncology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 8 countries.

Mikkael A Sekeres *Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA. msekeres@med.miami.edu.ORCID 0000-0003-2009-6524
Pau MontesinosHospital Universitari i Politècnic La Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
Jan NovakDepartment of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Jianxiang WangDepartment of Clinical Hematology, Institute of Hematology and Blood Diseases Hospital, Tianjin, China.ORCID 0000-0001-9437-9151
Deepa JeyakumarUniversity of California, Irvine, Chao Family Comprehensive Cancer Center, Orange, CA, USA.
Benjamin TomlinsonDivision of Hematology, University Hospitals of Cleveland Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA.ORCID 0000-0002-2407-0973
Jiri MayerDepartment of Internal Medicine Hematology and Oncology, University Hospital Brno and Masaryk University, Brno, Czech Republic.
Erin JouDepartment of Hematology/Oncology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, USA.
Tadeusz RobakDepartment of Hematology, Medical University of Lodz, Lodz, Poland.ORCID 0000-0002-3411-6357
David C TaussigThe Royal Marsden Hospital, London, UK.
Hervé DombretInstitut de Recherche Saint-Louis, Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France.
Akil MerchantDivision of Hematology and Cellular Therapy, Cedars Sinai Cancer, Los Angeles, CA, USA.ORCID 0000-0001-7472-822X
Naveed ShaikPfizer Oncology, Pfizer Inc, San Diego, CA, USA.
Thomas O'BrienPfizer Oncology, Pfizer Inc, San Diego, CA, USA.
Whijae RohPfizer Oncology, Pfizer Inc, San Diego, CA, USA.
Xueli LiuPfizer Oncology, Pfizer Inc, San Diego, CA, USA.
Wendy MaPfizer Oncology, Pfizer Inc, San Diego, CA, USA.
Christine G DiRienzoPfizer Inc, Collegeville, PA, USA.
Geoffrey ChanPfizer Inc, Collegeville, PA, USA.
Jorge E Cortes *Georgia Cancer Center, Augusta, GA, USA. jorge.cortes@augusta.edu.ORCID 0000-0002-8636-1071
Pfizer (United States) · USAugusta University Health · USCedars-Sinai Medical Center · USCharles University · CZHofstra University · USInstitute of Hematology & Blood Diseases Hospital · CNInstituto de Salud Carlos III · ESMasaryk University · CZMedical University of Lodz · PLRoyal Marsden Hospital · GBUniversité Paris Cité · FRUniversity Hospitals of Cleveland · USUniversity of California, Irvine · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.

Indexed as

AnemiaLeukemia, Myeloid, AcuteAntineoplastic Combined Chemotherapy ProtocolsAzacitidineBenzimidazolesCytarabineDaunorubicinHumansNauseaPhenylurea CompoundsAzacitidineBenzimidazolesCytarabineDaunorubicinglasdegibPhenylurea Compounds

Identifiers

PMID37604981
PMCPMC10539167
OpenAlexW4386022358

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.