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A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

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Trial Profile

A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

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

Latest Information Update: 23 May 2024

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At a glance

  • Drugs Ibrutinib (Primary) ; Cyclophosphamide; Fludarabine; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 12 Dec 2023 Results assessing the impact of targeted agents in fully mitigating the detrimental effects of CLL on overall survival by comparing the 5-year OS of treatment-naive CLL pts in phase 3 clinical trials with the 5-year OS of age- and gender-matched general population (AGMGP) in Italy and the US (RESONATE2, ILLUMINATE, ALLIANCE, ELEVATE-TN, CLL14, GLOW, ECOG1912, FLAIR, and CLL13) were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 12 Oct 2023 Results published in the Blood
    • 11 Aug 2023 Planned End Date changed from 1 Dec 2024 to 31 Dec 2024.
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