SHINE MCL3002
Research type
Research Study
Full title
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
IRAS ID
125747
Contact name
Simon Rule
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2012-004056-11
Clinicaltrials.gov Identifier
U1111-1137-0389, Universal Trial Number
Duration of Study in the UK
6 years, 5 months, 4 days
Research summary
This is a randomised, double-blind, placebo-controlled, multi-centre Phase 3 study to evaluate whether the addition of ibrutinib to standard treatment (bendamustine (B) and rituximab (R)) will result in prolongation of progression-free survival (PFS) in patients with newly diagnosed Mantle Cell Lymphoma (MCL) aged 65 years or older.
Despite recent advances in the treatment ofMCL and despite improvements in overall survival rates to approximately 5 years, there is an unmet medical need for newly diagnosed MCL patients who are aged 65+ years.
Based on recent data, a BR regimen followed by R maintenance is an accepted treatment option for patients who are 65 years of age or older.
Results from Phase 1 and Phase 2 studies of ibrutinib in combination with BR demonstrate promising early efficacy. As an oral daily treatment, ibrutinib may offer a treatment option to this patient population.
Participation will involve a Screening Phase (up to 30 days), a treatment phase (up to 30 x 28-day cycles) and a post-treatment follow-up phase.
Approximately 520 patients will be randomised to 1 of 2 treatment groups (BR plus either placebo or ibrutinib) in a 1:1 ratio. All subjects will receive open-label BR background therapy for a maximum of 6 x 28-day cycles. Patients with a complete (CR) or partial response (PR) will continue to receive R maintenance every second cycle up to cycle 30, or until disease progression, unacceptable toxicity, or study end. Study drug (ibrutinib or placebo) will be administered daily and continuously.
After cycle 30, patients with CR or PR will continue to receive ibrutinib or placebo continuously until disease progression, unacceptable toxicity, or study end.
Response to treatment will be evaluated through radiological assessment (CT/MRI) and assessed by the Investigator at the site. CR/PR and disease progression will be confirmed by PET scan.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
13/WM/0114
Date of REC Opinion
27 Mar 2013
REC opinion
Favourable Opinion