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A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

Trial Profile

A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Bendamustine (Primary) ; Obinutuzumab (Primary) ; Venetoclax (Primary)
  • Indications Chronic lymphocytic leukaemia; Tumour lysis syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie
  • Most Recent Events

    • 31 Jul 2023 Status changed from active, no longer recruiting to completed.
    • 07 Oct 2022 Planned End Date changed from 19 Jul 2023 to 20 Jul 2023.
    • 14 Dec 2021 Results (n=120) assessing the safety and efficacy of obinutuzumab with or without bendamustine as a debulking regimen before venetoclax treatment in the outpatient community setting and the safety and efficacy of subsequent venetoclax plus obinutuzumab treatment after debulking was also evaluated, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
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