Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

You may be eligible if

• Biopsy-proven diagnosis of Grade 1 or 2 follicular non-Hodgkin's lymphoma with no evidence of transformation to large cell histology.
• Meet criteria for Low Tumor Burden:
• * No nodal or extra nodal mass ≥ 7 centimeter (cm)
• * \<3 nodal masses \>3 cm in diameter
• * No systemic symptoms or B symptoms
• * No splenomegaly \>16 cm by CT scan
• * No risk of compression of a vital organ.
• * No leukemic phase with \>5000/mm³ circulating lymphocytes.
• No cytopenias defined as:
• * Platelets \<100,000/mm³
• * Hemoglobin (Hgb) \<10 g/dL
• * Absolute Neutrophil Count (ANC) \<1500/mm³
• Must have Stage III or Stage IV disease.
• Baseline measurements/evaluations obtained within 6 weeks of registration. Patient must have at least one objective measurable disease parameter.
• Age ≥ 18 years.
• Eastern Oncology Cooperative Group Performance Status 0-1.
• Must not have received investigational agents within 30 days of registration.
• Signed Institutional Review Board (IRB)-approved informed consent.
• Willing to provide blood samples for research purposes.
• Women must not be pregnant or breastfeeding.
• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.
• No prior chemotherapy, radiotherapy or immunotherapy for lymphoma.
• No prior treatment with cytotoxic drugs or rituximab for a previous cancer or another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody.
• No prior use of any monoclonal antibody within 3 months of randomization.
• No history of severe allergic/anaphylactic reactions to humanized/murine monoclonal antibodies or known sensitivity/allergy to murine products.
• No history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 2 years and did not require treatment with cytotoxic drugs or rituximab.
• No major surgery within 4 weeks prior to randomization, other than for diagnosis.
• Must be Human Immunodeficiency Virus (HIV) negative.
• Have adequate organ function without growth factor and/or transfusion support within ≤ 2 weeks prior to registration:
• * ANC ≥ 1500/mm³
• * Hgb ≥ 10 g/dL
• * Platelets ≥ 100,000/mm³
• * Serum Creatinine ≤ 2x Upper Limit Normal (ULN)
• * Total Bilirubin ≤ 2x ULN
• * AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ≤ 5x ULN
• * PTT (Partial Thromboplastin Time) or aPTT (activated Partial Thromboplastin Time) \>1.5x the ULN in the absence of a lupus anticoagulant
• * INR (International Normalized Ratio) \>1.5x the ULN in the absence of therapeutic anticoagulation
• No active, uncontrolled infections (afebrile for ≥ 48 hours off antibiotics).
• Must not receive immunization with attenuated live vaccines within 28 days prior to registration or during the study period.
• Must be tested for hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (anti-HBc) within 2 weeks of registration. Patients who are chronic carriers of HBsAg and anti-HBc are excluded.
• Must be tested for hepatitis C antibody within 2 week of registration. If this test is positive, patients are excluded unless a hepatitis C virus ribonucleic acid (HCV RNA) is negative.
• No evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (i.e., severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease.