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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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.

This Tabular View shows the required WHO registration data elements as marked by ^†

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
Links

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.