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A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

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Trial Profile

A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Ibrutinib (Primary)
  • Indications Mantle-cell lymphoma
  • Focus Therapeutic Use
  • Acronyms SPARK
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 07 Dec 2019 Results of a 7.5 year pooled analysis (n=370) of patients with relapsed/refractory Mantle-cell-lymphoma from three trials (SPARK, RAY and PCYC-1104) were presented at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #1538).
    • 07 Dec 2019 Results of 7.5 year pooled analysis (n=370) from SPARK, RAY and PCYC-1104 trials presented in the AbbVie media release.
    • 06 Nov 2019 Results of updated pooled analysis from four trials (SPARK, RAY, PCYC-1104 and CAN3001) with 15 months (mos) of additional follow-up, and a comparison of outcomes with ibrutinib versus the prior regimen, were released in the 61st Annual Meeting and Exposition of the American Society of Hematology.

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