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An open-label, multi-Center, uncontrolled phase I/II study in patients with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL)

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Trial Profile

An open-label, multi-Center, uncontrolled phase I/II study in patients with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Tirabrutinib (Primary) ; Prednisolone
  • Indications CNS cancer; Lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms ONO-4059-02
  • Sponsors Ono Pharmaceutical

Most Recent Events

  • 12 Dec 2023 Results of post-hoc analyses of the 37-month follow-up data, presented at the 65th American Society of Hematology Annual Meeting and Exposition
  • 06 Jun 2023 Results of final three-year follow-up analysis of phase I/II study on tirabrutinib in patients with relapsed or refractory primary central nervous system lymphoma presented at the 59th Annual Meeting of the American Society of Clinical Oncology
  • 21 Feb 2022 According to a Ono Pharmaceutical media release, based on results from this study the Velexbru approved in Taiwan by the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma for which no standard of care has been established.

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