A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma

Trial Profile

A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma

Completed
Phase of Trial: Phase II

Latest Information Update: 29 Nov 2016

At a glance

  • Drugs Bendamustine (Primary)
  • Indications Chronic lymphocytic leukaemia
  • Focus Therapeutic Use
  • Sponsors SymBio Pharmaceuticals
  • Most Recent Events

    • 26 Aug 2016 Acording to Eisai media release, the Ministry of Health, Labour and Welfare approved bendamustine [Treakisym] 100 mg injection for chronic lymphocytic leukaemia in Japan. SymBio Pharmaceuticals filed an application in December 2015, after receiving a development request from the Japanese Ministry of Health, Labour and Welfare's Study Group on Unapproved and Off Label Drugs.
    • 24 Dec 2015 According to a SymBio Pharmaceuticals media release, the company submitted the supplemental New Drug Application to the Pharmaceuticals and Medical Devices Agency in Japan for bendamustine [Treakisym] for chronic lymphocytic leukaemia.
    • 19 Oct 2015 Status changed from active, no longer recruiting to completed, according to a SymBio Pharmaceuticals media release.
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