A Randomized, Open-Label, Multicenter Phase 2 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
- Male or female patients 18 years or older.
- Newly Diagnosed non-GCBsubtype 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
- Male subjects must agree to use a double barrier method of birth control
- Prior treatment with VELCADE.
- Prior extended radiotherapy or chemotherapy for lymphoma
- More that 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