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A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

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Trial Profile

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

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

Latest Information Update: 21 Mar 2024

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At a glance

  • Drugs Acalabrutinib (Primary) ; Ibrutinib
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ACP-196; ELEVATE-RR; Head-to-Head trial
  • Sponsors Acerta Pharma

    • Most Recent Events

    • 12 Dec 2023 Results assessingSimilar Efficacy of Ibrutinib Arms across ALPINE and ELEVATE-RR Trials in Relapsed/Refractory Chronic Lymphocytic Leukemia, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 12 Dec 2023 Results of pooled analysis from CL001 , CL003 , CL006, CL007 and CL309 , presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 29 Nov 2023 According to an AstraZeneca media release, analysis of 5 studies (CL-001, CL-003, CL-006, CL-007 & CL-309) showing acceptable safety outcomes based on rates of nonfatal and fatal ventricular arrhythmias and sudden death in patients with CLL will be presented at 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA, 9 to 12 December 2023.
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