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A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

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Trial Profile

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

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

Latest Information Update: 28 Sep 2026

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At a glance

  • Drugs Pirtobrutinib (Primary) ; Acalabrutinib; Ibrutinib; Zanubrutinib
  • Indications Mantle-cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms BRUIN MCL-321
  • Sponsors Loxo Oncology

Most Recent Events

  • 23 Sep 2026 Planned End Date changed from 1 Apr 2028 to 1 Jun 2030.
  • 23 Sep 2026 Planned primary completion date changed from 1 Jan 2027 to 1 Nov 2027.
  • 28 May 2025 Status changed from recruiting to active, no longer recruiting.

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