Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Eligibility Criteria for the Randomized Study Inclusion Criteria: * Untreated or previously treated for WM. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen * Centrally confirmed clinicopathological diagnosis of WM * Measurable disease defined as serum monoclonal immunoglobulin M (IgM) \>0.5 g/dL * Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment * Hematology and biochemical values within protocol-defined limits * Men and women ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Exclusion Criteria: * Known involvement of the central nervous system by WM * Disease that is refractory to the last prior rituximab-containing therapy defined as either * Relapse after the last rituximab-containing therapy \< 12 months since last dose of rituximab, OR * Failure to achieve at least a minor response (MR) after the last rituximab-containing therapy If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered * Rituximab treatment within the last 12 months before the first dose of study drug * Known anaphylaxis or (immunoglobulin E) IgE-mediated hypersensitivity to murine proteins or to any component of rituximab * Prior expos…