Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Condition: Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Bortezomib; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone
Intervention description: Bortezomib IV; Rituximab IV; Cyclophosphamide IV; Doxorubicin IV solution; Vincristine IV; Prednisone tablet
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without
      VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse
      Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to
      RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.
    

Eligibility criteria:

        Each patient must meet all of the following inclusion criteria to be enrolled in the study:

        Inclusion Criteria:

          -  Patients with previously untreated DLBCL that has been sub classified as the non-GCB
             subtype.

          -  At least 1 measurable tumor mass.

          -  Availability of paraffin block with sufficient tumor tissue.

          -  No evidence of central nervous system lymphoma.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2.

          -  Female patients who are post menopausal, surgically sterile, or agree to practice 2
             effective methods of contraception or abstain from heterosexual intercourse.

          -  Male patients who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse.

        Patients meeting any of the following exclusion criteria are not to be enrolled in the
        study:

        Exclusion Criteria:

          -  Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or
             evidence of active malignancy other than DLBCL.

          -  Peripheral neuropathy of Grade 2 or greater.

          -  Known history of human immunodeficiency virus (HIV) infection, unless receiving highly
             active antiretroviral therapy (HAART).

          -  Active infection requiring systemic therapy.

          -  Major surgery within 2 weeks before first dose.

          -  Patients with a left ventricular ejection fraction (LVEF) or less than 45%.

          -  Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled
             cardiovascular conditions as described in the protocol.

          -  History of allergic reaction/ hypersensitivity attributable to boron, mannitol,
             polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E
             (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.