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
- 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.