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
Study for patients with newly diagnosed Mantle Cell Lymphoma using study drug (BTK Inhibitor)
Sponsor: Janssen Research & Development LLC
Enrolling: Male and Female Patients
IRB Number: AAAL3027
U.S. Govt. ID: NCT01776840
Contact: Jennifer Amengual: 212 326 5720 / jea2149@columbia.edu
Additional Study Information: The purpose of this study is to compare the effects of Ibrutinib when it is given Bendamustine (known as Treanda) and Rituximab (known as Rituxan) to Bendamustine and Rituximab alone. Inbrutinib 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, Ibruntinib is tested to see if it may be useful in patients with MCL, who have not been treated for this disease before.
This study is closed
Investigator
Jennifer Amengual, MD
Do You Qualify?
Do you have a history of stroke or intracranial hemorrhage within 6 months prior to random assignment? Yes No
Do you have a history of cardiovascular disease? Yes No
Have you received therapy for MCL before? Yes No
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For more information, please contact:
Jennifer Amengual
jea2149@columbia.edu
212 326 5720
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