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

Gilead Sciences

Status and phase: Terminated; Phase 2

Conditions: Waldenstrom Macroglobulinemia

Treatments: Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113802

IM-T-hLL2-18-US

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)