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A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

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Trial Profile

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

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

Latest Information Update: 12 Dec 2025

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At a glance

  • Drugs Obinutuzumab (Primary) ; Venetoclax (Primary) ; Chlorambucil
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLL14
  • Sponsors Roche

Most Recent Events

  • 20 Nov 2025 According to a Chugai pharmaceutical media release, based on the results of clinical studies, including phase III CLL14 (BO25323) and phase II M20-353 studies, the company announced updates to the electronic package insert for the anti-cancer agent and humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg.
  • 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 Dec 2023 Results of pooled analysis from CLL13 and CLL14 studies assessing toxicity and efficacy , presented at the 65th American Society of Hematology Annual Meeting and Exposition

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