Spots Global Cancer Trial Database for Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia

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Trial Identification

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

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

Study ID: NCT00113802

Conditions

Waldenstrom Macroglobulinemia

Interventions

Epratuzumab (hLL2- anti-CD22 humanized antibody)

Study Description

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

Detailed Description: 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.