PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

Inclusion Criteria

• •1. Histologically proved NHL (B and T cells) according to WHO criteria and have relapsed or are refractory to at least 2 prior systemic chemotherapies (excluding chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia).
• •2. Measurable disease as assessed by IHP criteria (Appendices A and B).
• •3. Age ≥ 20 years.
• •4. ECOG performance status of 0-2.
• •5. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 2 weeks prior to first dose of study treatment.
• •6. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment. Surgery for placement of vascular access devices is acceptable.
• •7. Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.
• •8. Informed consent must be obtained prior to study initiation.
• •9. No concurrent investigational studies are allowed.
• •10. Absolute neutrophil count (ANC) \>750/µL.
• •11. Platelets \>50,000/µL.
• •12. Serum uric acid ≤ 8 mg/dL (with or without medication control).
• •13. Creatinine clearance must be ≥ 30 mL/min. This can be calculated using the Cockcroft-Gault equation: estimated creatinine clearance = \[(140 - age) x weight (in kg)\] / serum creatinine (in mg/dl) x 72; for females, multiple result by 0.85.