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

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