Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed follicular non-Hodgkin lymphoma (NHL) meeting 1 of the following criteria:
• •* Bulky (i.e., single mass ≥ 7cm in any uni-dimensional measurement) stage II disease
• •* Stage III or IV disease
• •WHO grade 1, 2, or 3a disease
• •Bone marrow biopsies allowed provided they are submitted in conjunction with nodal biopsies
• •* No fine-needle aspirates for diagnosis
• •Tumor tissue must express the CD20-positive antigen by flow cytometry or IHC
• •At least 1 site of measurable disease that is \> 1 cm in diameter in ≥ 1 dimension present either on physical exam or imaging studies
• •* Non-measurable disease alone not allowed, including the following:
• •* Bone lesions (lesions if present should be noted)
• •* Ascites
• •* Pleural/pericardial effusion
• •* Lymphangitis cutis/pulmonis
• •* Bone marrow (involvement by NHL should be noted)
• •Low- or intermediate-risk disease by the Follicular Lymphoma International Prognostic Index (FLIPI)
• •* FLIPI score meeting 1 or 2 of the following risk factors:
• •* Age \> 60 years
• •* Involvement of \> 4 nodal sites
• •* Stage III-IV disease
• •* Hemoglobin \< 12.0 g/dL
• •* LDH normal
• •* Risk determined by the following:
• •* Low Risk: 0-1 of the above risk factors
• •* Intermediate Risk: 2 risk factors
• •* Poor Risk: ≥ 3 risk factors
• •No known CNS involvement
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •ANC ≥ 1,000/μL
• •Platelet count ≥ 75,000/μL
• •Creatinine clearance ≥ 30 mL/min
• •Bilirubin ≤ 2 times upper limit of normal (unless secondary to Gilbert syndrome or hepatic involvement of NHL)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• •Patients with HIV infection allowed provided the following criteria are met:
• •* No evidence of coinfection with hepatitis B or C
• •* CD4+ cell count ≥ 400/mm³
• •* No evidence of resistant strains of HIV
• •* HIV viral load \< 10,000 copies HIV RNA/mL if not on anti-HIV therapy OR HIV viral load \< 50 copies if on anti-HIV therapy
• •* No history of AIDS-defining conditions
• •No evidence of active hepatitis B (HBV) or C (HCV) infection (i.e., no positive serology for anti-HBc or anti-HCV antibodies)
• •* HBV seropositivity allowed (HBsAg+) provided they are closely monitored for evidence of active HBV infection by HBV DNA testing
• •* After completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine (required)
• •PRIOR CONCURRENT THERAPY:
• •No prior chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy) for NHL
• •* Prior involved-field radiation therapy allowed
• •More than 2 weeks since prior corticosteroids except for maintenance therapy for a non-malignant disease
• •* No concurrent dexamethasone or other steroids as antiemetics
• •No live virus vaccination within 6 weeks prior to study entry
• •No concurrent zidvoudine or stavudine