65 years of age or older mantle cell lymphoma Untreated, stage II to IV disease
Ibrutinib (N:261) or placebo (N:262), bendamustine and rituximab (induction treatment)
Patients with an objective response continued to receive ibrutinib or placebo, plus rituximab
Efficacy
mPFS:80.6 m vs 52.9 m (HR: 0.75; 95% CL, 0.59-0.96; P=0.01)
CR: 65.5% vs 57.6% (P=0.06
Safety
Grade >= 3 AEs: 81.5% vs 77.3%
Grade >=3 AEs; neutropenia 47.1% vs 48.1%, pneumonia 20.1% vs 14.2%, lymphopenia 16.2% vs 11.9%, anemia 15.4% vs 8.8%, thrombocytopenia 12.7% vs 13.1%, rash 12.0% vs 1.9%, leukopenia 10.0% vs 11.2%
