A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia

Inclusion Criteria:

Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
Adequate organ function.
Detectable CD20 positive of the tumor cells.
Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.

Exclusion Criteria:

Treatment of WM within the past 28 days.
Treatment with rituximab or alemtuzamab within the past 3 months.
Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
Current participation in another interventional clinical study.
Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
Active cerebrovascular disease.