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A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Not Recruiting
Trial ID: NCT00811733
Purpose
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).
Official Title
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Eligibility
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.
Intervention(s):
biological: Ofatumumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061