An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of
RCHOP With or Without VELCADE in Previously Untreated Patients with Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma

Summary:
You have been asked to participate in this study because you have been recently diagnosed with diffuse large B-cell lymphoma.   This study will look at subjects with a certain type of diffuse large B-cell lymphoma, known as non-germinal center (non-GCB) diffuse large B-cell lymphoma.  We will need to look at your tumor tissue sample to determine if you have this specific type of diffuse large B-cell lymphoma.  If you do not have this certain type of diffuse large B-cell lymphoma you will not be eligible to participate in this trial

The main purpose of this study is to determine whether the addition of VELCADE to a commonly used drug combination for subjects with diffuse large B-Cell lymphoma called RCHOP (ritxuximab, cyclophosphamide, doxorubicin, vincristine and prednisone) benefits subjects with non-GCB diffuse large B-cell lymphoma and whether this combination can be given safely.  RCHOP is standard of care for this type of cancer.

Another purpose of this study is to look for disease markers. These disease markers, called “biomarkers,” in your blood and tumor, are special chemical characteristics that are different between subjects that respond to treatment and those that do not. These disease markers will be examined to see if they are turned on or off before treatment.

Eligibility and Treatment Plan:

• Age 18 and older
• Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
• At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis.
• No evidence of central nervous system lymphoma.

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