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

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

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Nov 2016

At a glance

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

    • 19 Oct 2015 Status changed from active, no longer recruiting to completed according to ClinicalTrials.gov record.
    • 30 Jul 2015 According to Janssen Inc., media release, company announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for IMBRUVICA for the treatment of patients with relapsed/refractory mantle cell lymphoma.
    • 20 May 2015 Results presented at the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
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