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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00113802
Recruitment Status : Terminated (low accrual)
First Posted : June 13, 2005
Last Update Posted : February 6, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Drug: Epratuzumab (hLL2- anti-CD22 humanized antibody) Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia
Study Start Date : August 2004
Primary Completion Date : December 2006
Study Completion Date : December 2006


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Serum measurements of IgM will be the primary determination of efficacy.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00113802     History of Changes
Other Study ID Numbers: IM-T-hLL2-18-US
First Posted: June 13, 2005    Key Record Dates
Last Update Posted: February 6, 2008
Last Verified: February 2008

Keywords provided by Immunomedics, Inc.:
Epratuzumab (hLL2- anti-CD22 humanized antibody)
Waldenstrom's Macroglobulinemia
Waldenstrom Macroglobulinemia
Hematologic Disease
Hematologic Diseases
Paraproteinemias
Vascular Hemostatic Disorders
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs