OHSU

IRB #

IRB00009556

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

Stephen Spurgeon

Study Purpose

The purpose of this study is to compare the effects, good and/or bad, of the study drug PCI-32765 (Ibrutinib) with bendamustine and rituximab on participants with newly diagnosed Mantle Cell Lymphoma.

Medical Condition(s)

Newly diagnosed Mantle Cell Lymphoma

Eligibility Criteria

Participant is 65 years of age or older
Newly diagnosed with Mantle Cell Lymphoma
No prior therapies for Mantle Cell Lymphoma

Age Range

65 - 99

Healthy Volunteers Needed

No

Duration of Participation

Approximately 6.5 years, with long-term follow-up.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Janssen Research & Development LLC

Recruitment End

04/10/2015

Compensation Provided

No


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