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

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