Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: ofatumumab
Intervention description: Given IV
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them.

      PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in
      treating patients with previously untreated stage II, stage III, or stage IV follicular
      non-Hodgkin lymphoma.
    

Eligibility 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