Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

Inclusion Criteria:

• Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
• No prior bortezomib therapy.
• Voluntary written informed consent.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
• Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
• 18 years of age or older.
• aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

• Platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
• Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
• Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
• ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
• Female subject is pregnant or lactating.
• Received other investigational drugs for this disease within 14 days of enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Known HIV+ status.
• Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.