Status:
COMPLETED
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Waldenstrom Macroglobulinaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00811733
Start Date
March 1 2009
End Date
February 1 2014
Last Update
May 30 2017
Active Locations (7)
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1
GSK Investigational Site
Los Angeles, California, United States, 90095-6984
2
GSK Investigational Site
Stanford, California, United States, 94305
3
GSK Investigational Site
Rochester, Minnesota, United States, 55905
4
GSK Investigational Site
Buffalo, New York, United States, 14263