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Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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Trial Profile

Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2024

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At a glance

  • Drugs Ibrutinib (Primary) ; Chlorambucil
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms RESONATE-2
  • Sponsors Pharmacyclics

    • 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.
    • 15 Jun 2023 Results of pooled analysis of 3 studies (RESONATE-2, ECOG1912, and iLLUMINATE) assessing the time to disease progression (PD) in previously untreated patients with CLL who were treated with ibrutinib, excluding patients who died prior to PD, presented at the 28th Congress of the European Haematology Association.
    • 14 Jun 2023 Results assessing frequency and time to detection of BTK and PLCG2 mutations in peripheral blood samples across 5 clinical trials (NCT01500733, NCT01578707, NCT01722487, NCT01744691 and NCT02264574) published in the Clinical Cancer Research
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