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High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

Trial Profile

High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

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

Latest Information Update: 04 Oct 2023

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At a glance

  • Drugs Aldesleukin (Primary) ; Dinutuximab beta (Primary) ; Busulfan; Busulfan; Carboplatin; Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Filgrastim; Interleukin-2; Isotretinoin; Melphalan; Vincristine
  • Indications Neuroblastoma
  • Focus Registrational; Therapeutic Use
  • Acronyms SIOPEN
  • Most Recent Events

    • 28 Jul 2023 According to a Recordati media release, to obtain FDA approval of a Biologics License Application (BLA) for the registration of Qarziba in the United States, preparatory activities are ongoing for a Type C Meeting with the FDA, expected in second half of 2023.
    • 06 Jun 2023 Results (n=414) assessing risk factors and outcomes for patients < 18 months with MNA neuroblastoma presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 22 Dec 2021 This trial has been completed in Slovenia (Global end date: 31 Mar 2018).
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