Brief Title
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Official Title
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
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 this phase II trial of ofatumumab is being initiated in patients
with Waldenstrom's Macroglobulinemia (WM).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
Secondary Outcome
Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
Condition
Waldenstrom Macroglobulinaemia
Intervention
Ofatumumab
Study Arms / Comparison Groups
Ofatumumab
Description: Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
37
Start Date
March 1, 2009
Completion Date
February 1, 2014
Primary Completion Date
June 1, 2011
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
GSK Clinical Trials, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00811733
Organization ID
110921
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
March 2015