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| Sponsored by: |
Immunomedics, Inc. |
|---|---|
| Information provided by: | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00113802 |
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 |
| 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 |
| 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) |
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 |
Inclusion Criteria:
(Please consult with study site for full eligibility criteria)
Contacts and 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 | |
More Information
| Study ID Numbers: | IM-T-hLL2-18-US |
| Study First Received: | June 10, 2005 |
| Last Updated: | February 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00113802 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Epratuzumab (hLL2- anti-CD22 humanized antibody) Waldenstrom's Macroglobulinemia Waldenstrom Macroglobulinemia Hematologic Disease Waldenstrom's Macroglobulinemia |
Hematologic Diseases Paraproteinemias Vascular Hemostatic Disorders Lymphoproliferative Disorders |
|
Immunoproliferative Disorders Immunologic Factors Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Hemostatics Lymphatic Diseases Antibodies Waldenstrom Macroglobulinemia Hemorrhagic Disorders Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
|
Immunoproliferative Disorders Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Blood Protein Disorders Hematologic Diseases Physiological Effects of Drugs Vascular Diseases Paraproteinemias Hemostatic Disorders |
Pharmacologic Actions Lymphatic Diseases Antibodies Waldenstrom Macroglobulinemia Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |
