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

Purpose

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

Condition	Intervention	Phase
Waldenstrom Macroglobulinemia	Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody)	Phase II

Genetics Home Reference related topics:

aceruloplasminemia hemophilia

ChemIDplus related topics:

Epratuzumab Yttrium Y 90 Epratuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia

Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:

Serum measurements of IgM will be the primary determination of efficacy.

Estimated Enrollment:	31
Study Start Date:	August 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113802

Locations


United States, New York
	Weill Medical College of Cornell/ New York Presbyterian Hospital
	New York, New York, United States, 10021
	Columbia University College of Physicans & Surgeons
	New York, New York, United States, 10032

Sponsors and Collaborators

Immunomedics, Inc.

More Information

Study ID Numbers:	IM-T-hLL2-18-US
First Received:	June 10, 2005
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00113802
Health Authority:	United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:

Epratuzumab (hLL2- anti-CD22 humanized antibody)

Waldenstrom's Macroglobulinemia

Waldenstrom Macroglobulinemia

Hematologic Disease

Waldenstrom's Macroglobulinemia

Hematologic Diseases

Paraproteinemias

Vascular Hemostatic Disorders

Lymphoproliferative Disorders

Study placed in the following topic categories:

Immunoproliferative Disorders

Hematologic Diseases

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Hemostatic Disorders

Lymphatic Diseases

Waldenstrom Macroglobulinemia

Antibodies

Hemorrhagic Disorders

Waldenstrom macroglobulinemia

Lymphoproliferative Disorders

Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Blood Protein Disorders

Physiological Effects of Drugs

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Immunomedics, Inc.
Information provided by:	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00113802