Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
- Conditions
- Waldenstrom Macroglobulinemia
- Registration Number
- NCT00113802
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
- 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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Serum measurements of IgM will be the primary determination of efficacy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Weill Medical College of Cornell/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
Columbia University College of Physicans & Surgeons
🇺🇸New York, New York, United States