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A phase III prospective randomized comparison of imatinib at a dose of 400mg in combination with peg-interferon-alpha2a (Peg-IFNa2a) or cytarabine (Ara-C) versus imatinib at a dose of 600mg versus imatinib a dose of 400mg for previously untreated chronic myelogenous leukemia (CML) in chronic phase

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Trial Profile

A phase III prospective randomized comparison of imatinib at a dose of 400mg in combination with peg-interferon-alpha2a (Peg-IFNa2a) or cytarabine (Ara-C) versus imatinib at a dose of 600mg versus imatinib a dose of 400mg for previously untreated chronic myelogenous leukemia (CML) in chronic phase

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2021

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At a glance

  • Drugs Cytarabine (Primary) ; Imatinib (Primary) ; Peginterferon alfa-2a (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms French SPIRIT; SPIRIT

    • Most Recent Events

    • 01 Aug 2021 Primary endpoint (Overall survival improvement) has not been met, according to the results published in the Leukemia.
    • 01 Aug 2021 Results assessing the long-term outcomes of patients enrolled in the trial. Strategies concerning switches to a second-generation TKI (2GTKI) and discontinuation of treatment in DMR are reported, published in the Leukemia.
    • 10 Oct 2016 Status changed from active, no longer recruiting to completed.
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