Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Waldenstrom Macroglobulinaemia

Thank you

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

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:


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:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

August 2014

Related Keywords:

  • Waldenstrom Macroglobulinaemia
  • Waldenstrom's Macroglobulinemia
  • Ofatumumab
  • Waldenstrom Macroglobulinemia



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