Evidence map›Paper›PMID 38033284›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921.

Erica Brivio, Edoardo Pennesi, Marieke E Willemse, Alwin D R Huitema, Yilin Jiang, Harm D R van Tinteren, Vincent H J van der Velden, Berna H Beverloo, Monique L den Boer, Lukas A J Rammeloo and 26 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04258943 (A Phase I/II Study of Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia", Study ITCC-054/COG-AAML1921), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04258943 phase1 / phase2active not recruitingnot on this map

A Phase I/II Study of Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia", Study ITCC-054/COG-AAML1921

TypeinterventionalSponsorChildren's Oncology GroupRan2020 to 2028Enrolled60ConditionsPhiladelphia Chromosome Positive CML, Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous LeukemiaArmsBosutinib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026
    Review
  4. Article
  5. [How I treat pediatric chronic myeloid leukemia].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025
    Review
  6. Review
  7. Article
  8. 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

36 authors.

Erica BrivioDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0001-5285-1702
Edoardo PennesiDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0002-0920-8372
Marieke E WillemseDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Alwin D R HuitemaPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Yilin JiangDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Harm D R van TinterenPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0002-4626-8702
Vincent H J van der VeldenDepartment of Immunology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.ORCID 0000-0001-9457-3763
Berna H BeverlooDepartment of Clinical Genetics, Erasmus MC, Rotterdam, the Netherlands.ORCID 0000-0003-2280-7617
Monique L den BoerDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0002-5795-2921
Lukas A J RammelooDepartment of Pediatric Cardiology, Amsterdam UMC, Emma Children's Hospital, Amsterdam, the Netherlands.
Chad HudsonHematologics Inc, Seattle, WA.
Nyla HeeremaNationwide Children's Hospital, Columbus, OH.
Karey KowalskiPfizer Inc, New York, NY.
Huadong ZhaoPfizer Inc, New York, NY.
Luke KuttschreuterPfizer Inc, New York, NY.ORCID 0000-0002-3632-8740
Francisco J Bautista SirventPrincess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.ORCID 0000-0002-0421-8862
Andrew BukowinskiPediatric Hematology and Oncology Alabama, University of Alabama at Birmingham, Birmingham, AL.
Carmelo RizzariDepartment of Pediatrics, University of Milano-Bicocca, IRCCS San Gerardo dei Tintori, Monza, Italy.ORCID 0000-0002-4828-3893
Jessica PollardDana-Farber/Harvard Cancer Center, Boston, MA.ORCID 0000-0001-7307-9010
Laura Murillo-SanjuánHospital Universitari Vall d'Hebron, Barcelona, Spain.ORCID 0000-0001-6925-260X
Matthew KutnyChildren's Hospital of Alabama, Birmingham, AB.
Sara Zarnegar-LumleyVanderbilt University, Nashville, TN.ORCID 0000-0002-5413-371X
Michele RedellDan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX.ORCID 0000-0002-2515-3703
Stacy CooperSidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD.
Yves BertrandCHU Lyon, Hospices Civils de Lyon, Lyon, France.
Arnaud PetitHôpital Armand Trousseau, Paris, France.ORCID 0000-0001-8363-1622
Julie KrystalThe Steven and Alexandra Cohen Children's Medical Center of New York, New York, NY.ORCID 0000-0002-7997-1015
Markus MetzlerUniversitätsklinikum Erlangen, Erlangen, Germany.ORCID 0000-0002-4523-1676
Donna LancasterThe Royal Marsden NHS Foundation Trust, London, United Kingdom.
Jean-Pierre BourquinUniversity Children's Hospital, Zürich, Switzerland.ORCID 0000-0001-6571-6227
Jayashree MotwaniBirmingham Children's Hospital, Birmingham, United Kingdom.ORCID 0000-0001-8770-2686
Inge M van der SluisDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0002-5822-7668
Franco LocatelliIRCCS Ospedale Pediatrico Bambino Gesù, Catholic University of the Sacred Heart, Rome, Italy.ORCID 0000-0002-7976-3654
Michael E RothUniversity of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-6411-8353
Nobuko HijiyaColumbia University Irving Medical Center, New York, NY.ORCID 0000-0002-0199-054X
Christian M ZwaanDepartment of Pediatric Oncology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.ORCID 0000-0001-6892-8268

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeBosutinib is approved for adults with chronic myeloid leukemia (CML): 400 mg once daily in newly diagnosed (ND); 500 mg once daily in resistant/intolerant (R/I) patients. Bosutinib has a different tolerability profile than other tyrosine kinase inhibitors (TKIs) and potentially less impact on growth (preclinical data). The primary objective of this first-in-child trial was to determine the recommended phase II dose (RP2D) for pediatric R/I and ND patients. PATIENTS AND

methodsIn the phase I part of this international, open-label trial (ClinicalTrials.gov identifier: NCT04258943), children age 1-18 years with R/I (per European LeukemiaNet 2013) Ph+ CML were enrolled using a 6 + 4 design, testing 300, 350, and 400 mg/m

resultsThirty patients were enrolled; 27 were evaluable for DLT: six at 300 mg/m

conclusionBosutinib was safe and effective. The pediatric RP2D was 400 mg/m

Indexed as

Antineoplastic AgentsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseQuinolinesAdolescentAdultAniline CompoundsChildChild, PreschoolHumansInfantNitrilesProtein Kinase InhibitorsTreatment OutcomeAniline CompoundsAntineoplastic AgentsbosutinibNitrilesProtein Kinase InhibitorsQuinolines

Identifiers

PMID38033284
PMCPMC10906575

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.