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

Tracking Information
First Received Date ^ICMJE	June 10, 2005
Last Updated Date	February 4, 2008
Start Date ^ICMJE	August 2004
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Serum measurements of IgM will be the primary determination of efficacy.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00113802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Waldenstrom Macroglobulinemia
Intervention ^ICMJE	Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	31
Completion Date	December 2006
Primary Completion Date	December 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00113802
Responsible Party
Study ID Numbers ^ICMJE	IM-T-hLL2-18-US
Study Sponsor ^ICMJE	Immunomedics, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Immunomedics, Inc.
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP