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A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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Trial Profile

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Zanubrutinib (Primary)
  • Indications Mantle-cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors BeiGene

    • Most Recent Events

    • 12 Dec 2023 Results assessing an updated analysis to indirectly compare the long-term efficacy between zanubrutinib (median follow up: 35.3 months) and orelabrutinib (median follow up: 23.8 months) in patients with R/R MCL, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 08 Jul 2023 Results (NCT03206970 and NCT03494179) assessing Indirect comparisons of efficacy of zanubrutinib versus orelabrutinib in patients with relapsed or refractory small lymphocytic lymphoma or relapsed or refractory mantle cell lymphoma published in the Investigational New Drugs
    • 13 Dec 2022 Results of pooled analysis of two studies (phase I study (BGB-3111-AU-003, NCT02343120) and a phase II study (BGB-3111-206, NCT03206970)) compare long-term outcomes of second-line (with 1 prior line of therapy) vs later-line zanubrutinib treatment for relapsed/refractory mantle cell lymphoma patients, presented at the 64th American Society of Hematology Annual Meeting and Exposition.
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