|MDACC Study No:||2013-0056 (clinicaltrials.gov NCT No: NCT01776840)|
|Title:||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|
|Principal Investigator:||Jorge Romaguera|
|Treatment Agent:||Bendamustine HCl; Ibrutinib; Rituximab|
|Study Description:||The goal of this clinical research study is to compare the combination of |
ibrutinib, TreandaŽ (bendamustine), and RituxanŽ (rituximab) to bendamustine
and rituximab alone in the treatment of MCL. Some participants will receive a
placebo instead of ibrutinib.
Ibrutinib is designed to stop a protein from working in the cells, which may
cause the cancer cells to die or stop growing.
Bendamustine is designed to damage and destroy the DNA (genetic material) of
Rituximab is designed to attach to cancer cells and damage them, which may
cause the cancer cells to die.
A placebo is not a drug. It looks like the study drug but is not designed to
treat any disease or illness. It is designed to be compared with a study drug
to learn if the study drug has any real effect.