Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Immunomedics, Inc.
• Treatments: Antibodies; Epratuzumab; Immunoglobulins

Criteria

Inclusion Criteria:

• Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.

• Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis.

• Lymphoplasmacytic infiltration of the bone marrow >10% involvement.

• Failed at least one, but no more than 3, regimen(s) of prior therapy.

(Please consult with study site for full eligibility criteria)