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

Completed · Phase 2

Conditions studied: Waldenstrom Macroglobulinaemia

In brief

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).

Key facts

Study ID

NCT00811733

Run by

GlaxoSmithKline

People needed

37

Starts

2009-03-01

Expected to finish

2014-02-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — Buffalo, New York, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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