CLINICAL TRIAL SUMMARY

MDACC Study No:2013-0425 (clinicaltrials.gov NCT No: NCT01855750)
Title:A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine
Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab,
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With
Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Principal Investigator:Yasuhiro Oki
Treatment Agent:Cyclophosphamide; Doxorubicin; Ibrutinib; Prednisone; Rituximab; Vincristine
Study Status:Open
Study Description:The goal of this clinical research study is to learn if giving ibrutinib with
the combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and
prednisone (also known as R-CHOP) can help to control DLBCL, compared to
treatment with R-CHOP alone. The safety of this combination will also be
studied.

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


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Physician Name:Yasuhiro Oki
Dept:Lymphoma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:1-877-MDA-6789


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