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Sponsors and Collaborators: |
Wyeth Trubion Pharmaceuticals |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00521638 |
This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell Non-Hodgkin's Lymphoma (NHL).
TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data observed to date support its safety in patients with autoimmune disorders.
Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects with relapsed NHL (see inclusion criteria for subtypes).
Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.
Condition | Intervention | Phase |
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Lymphoma, B-Cell |
Biological: TRU-015 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Dose Escalation Study of TRU-015 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: TRU-015
Intravenous administration; 400 mg, 700 mg, or 1000 mg; 1x/week dosing for 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
The following histologies may be included*: lymphoplasmacytic lymphoma (formerly known as lymphoplasmacytoid lymphoma), splenic marginal zone B cell lymphoma, extranodal marginal zone B cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large-cell B cell lymphoma, and mediastinal large B cell lymphoma. Small lymphocytic lymphoma will be included if it is a primary diagnosis and if the lymphoma cells are < 5.0 x 109/L (5000/mm3) in the peripheral blood. *Subjects enrolled in the preliminary efficacy cohorts must have relapsed, refractory, or persistent follicular lymphoma (persistent disease defined as computed tomography (CT) positive for 3 months after last treatment), and must not have received anti-CD20 targeted therapy within 3 months of receiving the first dose of test article. Subjects may be considered eligible after a single therapy of probable clinical benefit, if no further standard effective treatment is available in the opinion of the investigator. Prior CD20 immunophenotyping of tumors to document B cell NHL is acceptable. If such prior documentation is not available, then the immunophenotype of the current disease must be documented by fine-needle aspirate or biopsy, or by circulating CD20-positive NHL cells from peripheral blood before administration of test article.
Main Exclusion Criteria:
United States, California | |
Duarte, California, United States, 91010 | |
San Diego, California, United States, 92121 | |
United States, Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02111 | |
United States, Missouri | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Buffalo, New York, United States, 14263 | |
United States, Ohio | |
Cleveland, Ohio, United States, 44195 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3206K2-104 |
Study First Received: | August 24, 2007 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00521638 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders |
B-cell Lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |