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

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

Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).

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.