QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed diagnosis of iNHL (Follicular lymphoma grade 1, 2, 3a; marginal zone lymphoma; small lymphocytic lymphoma or lymphoplasmacytic lymphoma) after treatment with at least 1 or more prior rituximab-containing regimens.
• * Anti-CD20 mAb-refractory disease is defined as progressive disease while on rituximab (or another treatment of an anti-CD20 monoclonal antibody) or progression within 6 months of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.
• * Anti-CD20 mAb-sensitive disease is defined by a response to a prior rituximab-containing (or another treatment of an anti-CD20 monoclonal antibody) regimen, and relapse more than 6 months from the last administration of rituximab-containing (or another treatment of an anti-CD20 antibody-containing) therapy.
• Measurable disease:
• * At least one lymph node group ≥ 1.5 cm in longest transverse dimension. Patients with cutaneous only disease may be enrolled if they have a clearly measurable skin lesion.
• * Relapsed or Refractory iNHL that has progressed during or following 1 or more prior systemic rituximab-containing (or another treatment of an anti-CD20 antibody-containing) regimens for lymphoma
• PRIOR/CONCURRENT THERAPY:
• No anti-lymphoma treatments within 28 days before the start of study treatment.
• Must have recovered from side effects of prior treatments.
• PATIENT CHARACTERISTICS:
• Performance Status
• ECOG 0, 1, or 2
• Renal Function • Glomerular Filtration Rate (GFR) \> 40mL/min or Serum creatinine ≤ 1.5 X ULN
• Bone Marrow Reserve
• Platelets ≥30,000/uL
• Hemoglobin ≥ 8g/dL
• Absolute Lymphocytes ≥800/uL
• ANC/AGC ≥750/uL
• Hepatic Function
• Total bilirubin ≤ 2.0 X ULN (unless Gilbert's Syndrome or disease infiltration of liver is present)
• AST, ALT ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver lymphoma is present)
• No positive Hep C serology or active Hep B infection
• Cardiovascular
• No congestive heart failure \< 6 months
• No unstable angina pectoris \< 6 months
• No myocardial infarction \< 6 months
• No history of ventricular arrhythmias or severe cardiac dysfunction
• No history of uncontrollable supraventricular arrhythmias
• No NYHA Class \> II CHF
• No marked baseline prolongation of QT/QTc interval
• Pulmonary
• Normal clinical assessment of pulmonary function
• Other
• Negative serum pregnancy test if female and of childbearing potential
• Women who are not pregnant or nursing
• Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
• No known autoimmune disease other than corrected hypothyroidism
• No known prior organ allograft or allogeneic transplantation
• Not HIV positive
• No active CNS involvement with lymphoma
• No psychiatric illness/social situation that would limit compliance
• No other illness that in the opinion of the investigator would exclude the subject from participating in the study
• Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
• No active systemic infection requiring parenteral antibiotic therapy
• No disease requiring systemic immunosuppressive therapy (inhaled or topical steroids are allowed). Adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
• No known histologic transformation from iNHL to DLBCL