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A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

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Trial Profile

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

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

Latest Information Update: 15 Jul 2024

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At a glance

  • Drugs Pirtobrutinib (Primary) ; Bendamustine; Idelalisib; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms BRUIN CLL-321
  • Sponsors Loxo Oncology
  • Most Recent Events

    • 24 Apr 2024 Status changed from recruiting to active, no longer recruiting.
    • 01 Dec 2023 According to an Eli Lilly and Company Media Release, data will be presented at an upcoming medical meeting.
    • 01 Dec 2023 Primary endpoint (To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigators choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)) has been met, according to an Eli Lilly and Company Media Release.
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