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A phase 3, multi-center, open label, randomized study of oral ABL001 (asciminib) versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

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Trial Profile

A phase 3, multi-center, open label, randomized study of oral ABL001 (asciminib) versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2025

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At a glance

  • Drugs Asciminib (Primary) ; Bosutinib
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEMBL
  • Sponsors Novartis; Novartis Pharmaceuticals; Novartis Pharmaceuticals Corporation

Most Recent Events

  • 06 Feb 2025 Status changed from active, no longer recruiting to completed.
  • 01 Sep 2024 Results of the subgroup analysis (96-weeks) of Japanese patients (asciminib, n = 13; bosutinib, n = 3) in the ASCEMBL study were published in the International Journal of Hematology.
  • 12 Dec 2023 Results assessing Impact of Mutations in Blood Cancer Related Genes on Clinical Outcomes in Chronic Myeloid Leukemia in Chronic Phase presented at the 65th American Society of Hematology Annual Meeting and Exposition

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