A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) 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.

- AST, ALT, total bilirubin < 3 times the upper limit of normal unless documented by
the treating physician to be secondary to underlying lymphoma.

- 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,
MUGA or cardiac MRI.