Status:
TERMINATED
Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
Lead Sponsor:
Gilead Sciences
Conditions:
Waldenstrom Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ov...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00113802
Start Date
August 1 2004
End Date
December 1 2006
Last Update
August 19 2021
Active Locations (2)
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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