A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Trial Profile

A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2018

At a glance

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

    • 01 Feb 2018 According to an Amgen media release,the CHMP of the EMA adopted a positive opinion recommending a label variation to include OS data from this study, supporting the conversion of the conditional marketing authorization to a full marketing authorization in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
    • 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.
    • 12 Dec 2017 Results assessing baseline biomarkers that were prognostic (disease-related) or predictive (treatment-related) of clinical outcomes, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
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