Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

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 Gibber'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