Obinutuzumab and Lenalidomide in Treating Patients With Previously Untreated Stage II-IV Grade 1-3a Follicular Lymphoma

Inclusion Criteria

• A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
• Able and willing to provide written informed consent and to comply with the study protocol
• Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)
• Must be in need of therapy as evidenced by at least one of the following criteria:
• Bulky disease defined as:
• A nodal or extranodal (except spleen) mass > 7 cm in its greater diameter or,
• At least 3 nodal or extranodal sites >= 3 cm in diameter
• Presence of at least one B symptom:
• Fever (> 38 C) not due to infectious etiology
• Night sweats
• Weight loss > 10% in the past 6 months
• Fatigue due to lymphoma
• Splenomegaly (> 13 cm)
• Compression syndrome (ureteral, orbital, gastrointestinal)
• Any of the following cytopenias due to lymphoma:
• Hemoglobin = upper limit of normal (ULN) or beta-2 microglobulin > ULN
• Stage II, III, or IV disease
• Eastern cooperative oncology group (ECOG) performance status = 1.0 x 10^9/L
• Platelet count > 75 x 10^9/L
• Serum aspartate transaminase (AST) or alanine transaminase (ALT) 30 ml/min calculated by modified Cockcroft-Gault formula
• Bilirubin = 5 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk
• Known history of human immunodeficiency virus (HIV), active hepatitis C virus, active hepatitis B virus infection, or any uncontrolled active systemic infection
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated
• Prior use of lenalidomide
• Concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of > 10 mg/day of prednisone) within 28 days of the first dose of study drug
• Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block
• Vaccinated with live, attenuated vaccines within 4 weeks of study entry
• Lactating or pregnant subjects
• Administration of any investigational agent within 28 days of first dose of study drug
• Patients who have undergone major surgery within 14 days
• Patients with the following:
• Bleeding diathesis or patients in whom prophylactic antithrombotic therapy is otherwise contraindicated
• Patients with prior deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial thromboembolism
• Patients with ischemic stroke or transient ischemic attack (TIA)