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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Waldenstrom Macroglobulinaemia

Treatments

Biological: Ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00811733

110921

Details and patient eligibility

About

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).

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.