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