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A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

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Trial Profile

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Asciminib (Primary) ; Bosutinib; Dasatinib; Imatinib; Nilotinib
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ASC4FIRST
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 08 Dec 2024 According to a Novartis media release, data from this trial presented at the 66th American Society of Hematology (ASH) Annual Meeting.
  • 25 Nov 2024 According to a Novartis media release, data from this trial will be presented at the 66th American Society of Hematology (ASH) Annual Meeting.
  • 29 Oct 2024 According to a Novartis media release, Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

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