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

This study has been terminated.
Study NCT00113802.   Last updated on February 4, 2008.   Information provided by Immunomedics, Inc.

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Descriptive Information Fields
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
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Serum measurements of IgM will be the primary determination of efficacy.
Secondary Outcome Measure 
Condition  Waldenstrom Macroglobulinemia
Intervention  Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  31
Start Date  August 2004
Completion Date December 2006
Eligibility 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)

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00113802
Organization ID IM-T-hLL2-18-US
Secondary IDs ††
Study Sponsor  Immunomedics, Inc.
Collaborators ††
Investigators 
Information Provided By Immunomedics, Inc.
Verification Date February 2008
First Received Date  June 10, 2005
Last Updated Date February 4, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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