Summary:
A Phase 3, Randomized, Double-blind, Placebo-controlled,
Multicenter Study of Bendamustine and Rituximab (BR) Alone
Versus in Combination with Acalabrutinib (ACP-196) in Subjects with
Previously Untreated Mantle Cell Lymphoma
Qualified Participants Must:
Men and women, 65 years of age and older
Pathologically confirmed MCL, with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11:14)(q13:q32) and/or overexpress cyclin D1.
MCL requiring treatment and for which no prior systemic anticancer therapies have been received
Presence of radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (as defined by Lugano Classification for NHL)
Qualified Participants May Receive:
Eliglible participants will receive study related treatment and procedures at no cost