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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-01

Study Completion Date

2014-02-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Waldenstrom Macroglobulinaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ofatumumab

Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type BIOLOGICAL

Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.

Interventions

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Ofatumumab

Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No