Evidence map›Paper›PMID 37078412›Full record

Trial reportCancer2023

Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial.

Vu H Duong, Amy S Ruppert, Alice S Mims, Uma Borate, Eytan M Stein, Maria R Baer, Wendy Stock, Tibor Kovacsovics, William Blum, Martha L Arellano and 27 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03013998 (A Master Protocol for Biomarker-Based Treatment of AML), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
7.8field-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.

NCT03013998 phase1 / phase2recruitingnot on this map

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

TypeinterventionalSponsorBeat AML, LLCRan2016 to 2028Enrolled3,000ConditionsPreviously Untreated Relapsed Refractory Acute Myeloid LeukemiaArmsSamalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Pandora's Box of AML: HowBiomedicines · 2025
    Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Cancers · 2023
    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

37 authors at 20 institutions in 2 countries.

Vu H DuongUniversity of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, USA.ORCID 0000-0003-0278-7727
Amy S RuppertDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Alice S MimsDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Uma BorateDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Eytan M SteinMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Maria R BaerUniversity of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, USA.
Wendy StockSection of Hematology/Oncology, University of Chicago, Chicago, Illinois, USA.
Tibor KovacsovicsHuntsman Cancer Institute, The University of Utah, Salt Lake City, Utah, USA.
William BlumWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0003-0111-7465
Martha L ArellanoWinship Cancer Institute, Emory University, Atlanta, Georgia, USA.ORCID 0000-0003-1636-1962
Gary J SchillerDavid Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, USA.
Rebecca L OlinHelen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, California, USA.
James M ForanHematology and Oncology, Mayo Clinic, Jacksonville, Florida, USA.ORCID 0000-0003-1673-1708
Mark R LitzowDepartments of Medical Oncology, Hematology, and Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Tara L LinDivision of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Kansas City, Kansas, USA.ORCID 0000-0002-0242-6449
Prapti A PatelUniversity of Texas Southwestern Medical Center Medical School, Dallas, Texas, USA.
Matthew C FosterLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Robert L RednerHillman Cancer Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Zeina Al-MansourDepartment of Medicine, University of Florida, Gainesville, Florida, USA.
Christopher R CogleDepartment of Medicine, University of Florida, Gainesville, Florida, USA.
Ronan T SwordsKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.
Robert H CollinsUniversity of Texas Southwestern Medical Center Medical School, Dallas, Texas, USA.
Jo-Anne VergilioFoundation Medicine, Cambridge, Massachusetts, USA.
Nyla A HeeremaDepartment of Pathology, College of Medicine, The Ohio State University, Columbus, Ohio, USA.
Leonard RosenbergThe Leukemia & Lymphoma Society, Rye Brook, New York, USA.
Ashley O YocumThe Leukemia & Lymphoma Society, Rye Brook, New York, USA.
Sonja MarcusThe Leukemia & Lymphoma Society, Rye Brook, New York, USA.
Timothy ChenDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Franchesca DrugganDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Mona StefanosDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Theophilus J GanaBiopharmatech Consulting, Inc., Leesburg, Virginia, USA.ORCID 0000-0002-3818-5202
Abigail B ShobenDivision of Biostatistics, College of Public Health, The Ohio State University, Columbus, Ohio, USA.
Brian J DrukerKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.
Amy BurdThe Leukemia & Lymphoma Society, Rye Brook, New York, USA.
John C ByrdInternal Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Ross L LevineMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Michael M BoyiadzisHillman Cancer Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
The Ohio State University · USLeukemia and Lymphoma Society · USEmory University · USMemorial Sloan Kettering Cancer Center · USOregon Health & Science University · USThe University of Texas Southwestern Medical Center · USUniversity of Florida · USUniversity of Maryland, Baltimore · USUPMC Hillman Cancer Center · USJacksonville College · USLEK Consulting (United States) · USMayo Clinic · USPHG Foundation · GBUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Cincinnati · USUniversity of Kansas Medical Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA047904
6 · The paper itself

Abstract

backgroundPatients with acute myeloid leukemia (AML) who have tumor protein p53 (TP53) mutations or a complex karyotype have a poor prognosis, and hypomethylating agents are often used. The authors evaluated the efficacy of entospletinib, an oral inhibitor of spleen tyrosine kinase, combined with decitabine in this patient population.

methodsThis was a multicenter, open-label, phase 2 substudy of the Beat AML Master Trial (ClinicalTrials.gov identifier NCT03013998) using a Simon two-stage design. Eligible patients aged 60 years or older who had newly diagnosed AML with mutations in TP53 with or without a complex karyotype (cohort A; n = 45) or had a complex karyotype without TP53 mutation (cohort B; n = 13) received entospletinib 400 mg twice daily with decitabine 20 mg/m

resultsThe composite CR rates for cohorts A and B were 13.3% (95% confidence interval, 5.1%-26.8%) and 30.8% (95% confidence interval, 9.1%-61.4%), respectively. The median duration of response was 7.6 and 8.2 months, respectively, and the median overall survival was 6.5 and 11.5 months, respectively. The study was stopped because the futility boundary was crossed in both cohorts.

conclusionsThe combination of entospletinib and decitabine demonstrated activity and was acceptably tolerated in this patient population; however, the CR rates were low, and overall survival was short. Novel treatment strategies for older patients with TP53 mutations and complex karyotype remain an urgent need.

Indexed as

Leukemia, Myeloid, AcuteTumor Suppressor Protein p53Antineoplastic Combined Chemotherapy ProtocolsDecitabineHumansIndazolesKaryotypeMorpholinesPyrazinesTreatment Outcome6-(1H-indazol-6-yl)-N-(4-morpholinophenyl)imidazo(1,2-a)pyrazin-8-amineDecitabineIndazolesMorpholinesPyrazinesTP53 protein, humanTumor Suppressor Protein p53acute myeloid leukemiadecitabineentospletinibhypomethylating agentstumor protein p53 (TP53)

Identifiers

PMID37078412
PMCPMC11225573
OpenAlexW4366462667

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.