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A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

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Trial Profile

A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Bosutinib (Primary) ; Imatinib
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms BELA
  • Sponsors Pfizer; Wyeth Pharmaceuticals

    • Most Recent Events

    • 15 Jun 2023 Results of post-hoc pooled analysis of B1871006 (NCT00261846), B1871007 (NCT00811070), B1871039 (NCT02228382, BYOND) B1871048 (NCT03128411), B1871008 (NCT00574873) & (B1871040, NCT01903733) assessing effect of BMI on the safety of bosutinib in patients with previously treated or newly diagnosed CML, presented at the 28th Congress of the European Haematology Association.
    • 17 Jun 2018 Results of pooled data from two phase 3 trials (BFORE and BELA), were presented at the 23rd Congress of the European Haematology Association.
    • 12 Dec 2017 Results of an integrated analysis of the phase 3 trials (BELA and BFORE) quantitatively assessing the impact of reducing the starting bosutinib dose from 500 mg/day to 400 mg/day on safety and efficacy outcomes, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.

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