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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00042913 |
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: epratuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL)
Relapsed or refractory after at least 1 regimen of standard therapy
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 |
Principal Investigator: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069484, UCLA-0201056, AMGEN-AMG-412-159, NCI-G02-2094 |
Study First Received: | August 5, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00042913 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Signs and Symptoms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
B-cell Lymphomas Lymphoma, Large-cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Recurrence |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |