A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)

Trial Profile

A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Jan 2018

At a glance

  • Drugs Blinatumomab (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Horai
  • Sponsors Amgen
  • Most Recent Events

    • 09 Jan 2018 According to an Amgen media release, the company has submitted in Japan a marketing authorization for blinatumomab to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The application for marketing approval in Japan was based on the results from multiple global clinical studies including the Phase 3 randomized study (TOWER study), and the Japanese Phase 1b/2 study.
    • 15 Nov 2017 Planned End Date changed from 22 Apr 2019 to 5 Aug 2019.
    • 18 Sep 2017 Planned End Date changed from 3 Feb 2020 to 22 Apr 2019.
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