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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014664 |
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: apolizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT) |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.
PROJECTED ACCRUAL: A total of 60 patients 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:
Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000068585, PDL-1D10-901, CUMC-0101-552 |
Study First Received: | April 10, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00014664 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Immunoproliferative Disorders Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Recurrence Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases |
Antibodies Chronic Lymphocytic Leukemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |