An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Key

Inclusion Criteria:

- The patient has histopathologic confirmation of one of the protocol-specific CD20+
B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed
within 6 months of study entry and with biopsy material available for review.

- The patient meets 1 of the following need-for-treatment criteria:

1. Presence of at least 1 of the following B-symptoms:

- fever (>38ºC) of unclear etiology

- night sweats

- weight loss of greater than 10% within the prior 6 months

2. large tumor mass (bulky disease) characterized by lymphomas with a diameter of
more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more
than 7 cm in 1 region

3. presence of lymphoma-related complications

4. hyperviscosity syndrome due to monoclonal gammopathy

- The patient's tumor is verified to be CD20+ positive from current or previous
excisional or incisional tissue diagnostic procedures performed within 6 months of
study entry.

- The screening phase CT scan (based on local evaluation) shows:

- 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or

- 1 clearly demarcated lesion with a largest diameter ≥2.0 cm

- The patient was not previously treated for indolent lymphoma (with the exception of a
single course of local radiation therapy not exceeding 2 adjacent lymph node
regions).

- The patient has adequate hematologic and hepatic function.

- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or
2.

- The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30
mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine
collection.

- The patient is willing to comply with contraception requirements.

Key Exclusion Criteria:

The patient:

- Has small lymphocytic lymphoma or mantle cell lymphoma.

- Has documented history of central nervous system (CNS) lymphomatous involvement.

- Has or has had an active malignancy, other than NHL, within the past 3 years except
for localized prostate cancer without evidence of bone metastases, bladder, cervical,
or breast carcinoma in-situ, or non-melanoma skin cancer .

- Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled
arrythmias or unstable angina, electrocardiographic evidence of active ischemia or
active conduction system abnormalities, or myocardial infarction within the last 6
months.

- Has known human immunodeficiency virus (HIV) infection.

- Has acute or chronic hepatitis B or hepatitis C infection.

- Is a pregnant or lactating woman. (Any women becoming pregnant during the study will
be withdrawn from the study.)

- Has any serious uncontrolled, medical or psychological disorder that would impair the
ability of the subject to receive study drugs.

- Has received another investigational agent within 30 days of study entry.

- Has known hypersensitivity to mannitol.

- Has Ann Arbor stage I disease.