Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Serum measurements of IgM will be the primary determination of efficacy. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.
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Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis.
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Lymphoplasmacytic infiltration of the bone marrow >10% involvement.
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Failed at least one, but no more than 3, regimen(s) of prior therapy.
(Please consult with study site for full eligibility criteria)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Weill Medical College of Cornell/ New York Presbyterian Hospital | New York | New York | United States | 10021 |
2 | Columbia University College of Physicans & Surgeons | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IM-T-hLL2-18-US