A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2017

At a glance

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

    • 06 Mar 2017 Planned End Date changed from 1 Oct 2019 to 10 Oct 2021.
    • 06 Mar 2017 Planned primary completion date changed from 1 Mar 2018 to 28 Mar 2018.
    • 17 Dec 2014 Status changed from recruiting to active, no longer recruiting, according to ClinicalTrials.gov record.
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