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
Participants in this study have been diagnosed with Mantle Cell Lymphoma (MCL). Mantle Cell Lymphoma is a type of cancer that affects the lymphatic system. The lymphatic system helps to fight infections and disease. Ibrutinib is known as a ¿Bruton¿s Tyrosine Kinase (BTK) inhibitor¿. This is an experimental drug that blocks an enzyme that affects how the lymphocytes grow and survive. Blocking this enzyme is an important mechanism in killing cancer cells. In this study, Ibrutinib is tested to see if it may be useful in patients with MCL, who have not been treated previously for this disease. The purpose of this study is to compare the effects (both good and bad) of Ibrutinib when it is given with Bendamustine (known as Treanda) and Rituximab (known as Rituxan) to Bendamustine and Rituximab alone.
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