A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Inclusion Criteria:

- Indolent lymphoma including Grades 1-3a follicular, small lymphocytic,
lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage
II. Tumor verified CD20+ and CT imaging done at screening verifying disease

- Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of
treatment with rituximab or a rituximab-containing regimen

- Indolent lymphoma including grades 1-3a follicular, small lymphocytic,
lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage
II (i.e. as any single mass > 5 cm in any direction)

- ECOG Performance Status of 0, 1, or 2

- Life expectancy of at least 6 months

- 18 years or older

- Signed, written informed consent

Exclusion Criteria:

- Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed
to aggressive lymphoma

- Previous allogeneic stem cell transplant

- Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy
in the past 12 months

- Previous external beam radiation therapy to the pelvis. Previous external beam
radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two
or to more than 3 vertebral bodies

- High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within
3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at
the time of randomization

- Prior bendamustine treatment within 1 year of randomization not resulting in a CR or
PR for at least 6 months

- Treatment with anti-CD20 monoclonal antibody within 3 months of randomization

- Known CNS involvement of indolent lymphoma

- Other past or current malignancy. Subjects free of malignancy for at least 5 years
or have history of definitively treated non-melanoma skin cancer, or successfully
treated in situ carcinoma, are eligible

- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment

- Clinically significant cardiac disease

- History of significant cerebrovascular disease or event with significant symptoms

- Positive serology for Hepatitis B

- Current active liver or biliary disease (except Gibler's syndrome or asymptomatic
gallstones, liver metastases, or otherwise stable chronic liver disease)

- Known HIV positive

- Abnormal/inadequate blood values, liver and kidney function

- Current participation in other clinical study

- Inability to comply with the protocol activities

- Lactating or pregnant women or female patients of child-bearing potential (or male
patients with such partners) not willing to use adequate contraception