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

Phase 2
18 Years
Open (Enrolling)
Waldenstrom Macroglobulinaemia

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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 SiteBakersfield, California  93309
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteNew York, New York  10021