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NCT00811733 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
A Phase 2 study of Waldenstrom Macroglobulinaemia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 7
- Study locations
NCT00811733: Completed Phase 2 study of Waldenstrom Macroglobulinaemia, sponsored by GlaxoSmithKline.
NCT00811733 is a Phase 2 study of Waldenstrom Macroglobulinaemia that has completed, run by GlaxoSmithKline. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00811733, a Phase 2 study of Waldenstrom Macroglobulinaemia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 7
- Study locations
Study 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).
Primary Outcome
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 f
Conditions Studied
Interventions
- BIOLOGICAL Ofatumumab
Study Locations (7)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Stanford
New York
- GSK Investigational Site - Buffalo
- GSK Investigational Site - New York
Minnesota
- GSK Investigational Site - Rochester
Ohio
- GSK Investigational Site - Columbus
Texas
- GSK Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2009-03-01 |
| Est. Completion | 2014-02-01 |
| Phase | Phase 2 |
What the finished NCT00811733 record still lists
NCT00811733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Waldenstrom Macroglobulinaemia appearing as the primary indexed condition, and to 1 intervention - of which Ofatumumab is the first listed.
NCT00811733 lists 7 locations in 5 states (California, New York, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00811733 about?
NCT00811733 is a clinical study titled "A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia". 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...
What is the current status of trial NCT00811733?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2009-03-01. Estimated completion is 2014-02-01.
What conditions does trial NCT00811733 study?
This clinical trial studies the following conditions: Waldenstrom Macroglobulinaemia.
What interventions are being tested in trial NCT00811733?
The interventions under investigation include: Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00811733?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00811733 being conducted?
This trial has 7 study locations across California, Minnesota, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00811733's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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