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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: 05 Nov 2025

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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

  • 19 Sep 2025 According to Nippon Shinyaku media release, announced that Eli Lilly Japan obtained additional approval for its antineoplastic agent Jaypirca 50 mg and 100 mg tablets as a treatment for patients with relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) who are resistant or intolerant to other BTK inhibitors on September 19, 2025. This sNDA approval is based on this study.
  • 28 Feb 2025 According to an Eli Lilly and Company Media Release, European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib). The positive opinion is supported by data from the BRUIN CLL-321 clinical trial.
  • 18 Dec 2024 According to an Checkpoint Therapeutics Media Release, Eli Lilly and Company presented promising results from this study at the 66th American Society of Hematology (ASH) Annual Meeting.

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