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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. Identifier: NCT00113802
Recruitment Status : Terminated (low accrual)
First Posted : June 13, 2005
Last Update Posted : February 6, 2008
Information provided by:
Immunomedics, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00113802

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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.
Layout table for additonal information Identifier: NCT00113802    
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
Vascular Hemostatic Disorders
Lymphoproliferative Disorders
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents