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A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

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Trial Profile

A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

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

Latest Information Update: 19 Apr 2025

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At a glance

  • Drugs Obinutuzumab (Primary) ; Venetoclax (Primary) ; Bendamustine; Cyclophosphamide; Fludarabine; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CRISTALLO
  • Sponsors Roche

    • Most Recent Events

    • 05 Nov 2024 According to Roche media release, company will present data of this trial at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US.
    • 17 Jul 2023 Planned End Date changed from 28 Jun 2025 to 31 Jul 2026.
    • 17 Jul 2023 Planned primary completion date changed from 29 Mar 2024 to 18 Mar 2024.

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