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

This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma Read More

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