A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
18 Years
N/A
Both
Waldenstrom Macroglobulinaemia
Trial Information
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
Outcome Description:
OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.
Outcome Time Frame:
Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
110921
NCT ID:
NCT00811733
Start Date:
March 2009
Completion Date:
August 2014
Related Keywords:
- Waldenstrom Macroglobulinaemia
- Waldenstrom's Macroglobulinemia
- Ofatumumab
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Duluth, Minnesota 55805 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | New York, New York 10021 |
