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Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue

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Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2024

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At a glance

  • Drugs Dinutuximab (Primary) ; Aldesleukin; Isotretinoin; Sargramostim; Sargramostim
  • Indications Neuroblastoma
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 29 Apr 2024 Planned End Date changed from 1 Dec 2016 to 7 Mar 2025.
    • 15 Apr 2024 According to a Norgine media release, on 13 Dec 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for high-risk neuroblastoma. The approval decision was based on findings from a trial comparing outcomes from Study 3b (NCT02395666; investigational arm) and Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm).
    • 26 Oct 2023 Results of Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons (from studies NCT02395666, NCT00026312)published in the Journal of Clinical Oncology

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