CLINICAL TRIAL SUMMARY

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 Status:Open
Study Description:The goal of this clinical research study is to compare the combination of
IMBRUVICAŽ (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
cancer cells.

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.

Hide details for General InformationGeneral Information

Disease Group:Lymphoma
Phase of Study:Phase III
Treatment Agents:Bendamustine HCl
Ibrutinib
Rituximab
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Janssen Research & Development, LLC
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Jorge Romaguera
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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