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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00113802
First received: June 10, 2005
Last updated: February 4, 2008
Last verified: February 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
United States, New York
Columbia University College of Physicans & Surgeons
New York, New York, United States, 10032
Weill Medical College of Cornell/ New York Presbyterian Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Immunomedics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00113802     History of Changes
Other Study ID Numbers: IM-T-hLL2-18-US
Study First Received: June 10, 2005
Last Updated: February 4, 2008
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
Hematologic Diseases
Paraproteinemias
Vascular Hemostatic Disorders
Lymphoproliferative Disorders

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

ClinicalTrials.gov processed this record on November 20, 2014