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Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
This study has been terminated.
( low accrual )
Study NCT00113802   Information provided by Immunomedics, Inc.
First Received: June 10, 2005   Last Updated: February 4, 2008   History of Changes

June 10, 2005
February 4, 2008
August 2004
December 2006   (final data collection date for primary outcome measure)
Serum measurements of IgM will be the primary determination of efficacy.
Same as current
Complete list of historical versions of study NCT00113802 on ClinicalTrials.gov Archive Site
 
 
 
Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia

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

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.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Waldenstrom Macroglobulinemia
Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
31
December 2006
December 2006   (final data collection date for primary outcome measure)

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00113802
 
IM-T-hLL2-18-US
Immunomedics, Inc.
 
 
Immunomedics, Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP