Education and Training

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).

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • biological: Ofatumumab

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting