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: 10 Jul 2019
At a glance
- Drugs Ibrutinib (Primary) ; Bendamustine; Rituximab
- Indications Mantle-cell lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms SHINE
- Sponsors Janssen Research & Development; Janssen-Cilag
- 29 Apr 2019 Planned primary completion date changed from 15 Nov 2019 to 15 May 2020.
- 07 Feb 2018 Planned primary completion date changed from 28 Mar 2018 to 15 Nov 2019.
- 06 Mar 2017 Planned End Date changed from 1 Oct 2019 to 10 Oct 2021.