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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2023

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At a glance

  • Drugs Dinutuximab beta (Primary) ; Aldesleukin; Busulfan; Busulfan; Carboplatin; Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Filgrastim; Isotretinoin; Melphalan; Vincristine
  • Indications Neuroblastoma
  • Focus Therapeutic Use
  • Acronyms HR-NBL-1; HR-NBL-1.7; HR-NBL-1.8; HR-NBL1-1.5; SIOPEN

    • Most Recent Events

    • 04 Oct 2023 Planned number of patients changed from 3300 to 3590.
    • 22 Dec 2021 This trial has been completed in Slovenia (Global end date: 31 Mar 2018).
    • 17 Aug 2021 According to a BeiGene media release, based on data from trials conducted by SIOPEN, China NMPA has granted dinutuximab beta conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma with or without residual disease.

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