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

A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia

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

This multi-center, single-arm study of epratuzumab is in patients with Waldenström's Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years, with evaluations every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until resolution of any treatment related abnormalities.

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)