Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: VELCADE; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
Intervention description: VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.; Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles; Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles; Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles; Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles; Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
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: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, active-control, parallel-group, multicenter, multinational
      Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide,
      Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin,
      Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center
      B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 18 years or older.

          -  Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).

          -  At least 1 measurable site of disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Female subjects must be postmenopausal (for at least 6 months), surgically sterile,
             abstinent, or, if sexually active, be practicing an effective method of birth control
             before entry and throughout the study; and have a negative pregnancy test at
             screening.

          -  Male subjects must agree to use a double barrier method of birth control

        Exclusion Criteria:

          -  Prior treatment with VELCADE.

          -  Prior extended radiotherapy or chemotherapy for lymphoma

          -  More than 150 mg/m2 of prior doxorubicin

          -  Major surgery within 3 weeks of study.

          -  Peripheral neuropathy or neuralgia of Grade 2 or worse.

          -  Active CNS lymphoma

          -  Diagnosed or treated for a malignancy other than NHL, with some exceptions

          -  Pregnant or breast feeding

          -  Active systemic infection

          -  Documented of suspected human immunodeficiency virus (HIV)/AIDS

          -  Uncontrolled or severe cardiovascular disease

          -  Known allergies, hypersensitivity or intolerance to study drugs

          -  Serious medical condition that could interfere with study

          -  Concurrent treatment with another investigational agent