Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) that can be challenging to treat. Many of the current treatments for MCL cannot be tolerated by older patients. Bendamustine and rituximab are drugs that have been shown to be effective against MCL with fewer side effects than another therapy called R-CHOP. Bendamustine/rituximab has not been approved by the U.S. Food and Drug Administration for treating newly diagnosed MCL, but they are used together in many countries to treat these patients.
Ibrutinib (PCI-32765) is a drug approved for treating MCL that has not responded to treatment or has returned after treatment, but its use in newly diagnosed patients is considered investigational. It works by blocking a protein inside the lymphoma cells called Bruton¿s tyrosine kinase, which helps the lymphoma cells to live and grow.
In this study, researchers are evaluating the effectiveness of bendamustine/rituximab with ibrutinib in patients newly diagnosed with MCL who are age 65 or older. Patients will be randomly assigned to receive either bendamustine/rituximab with ibrutinib, or bendamustine/rituximab with a placebo. Ibrutinib is a capsule that is taken orally (by mouth), while bendamustine and rituximab are given intravenously (by vein).