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Sponsored by: |
Applied Molecular Evolution |
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Information provided by: | Applied Molecular Evolution |
ClinicalTrials.gov Identifier: | NCT00354926 |
The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients, but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells. A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody. This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Biological: AME-133v (LY2469298) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Multicenter, Phase 1/2 Dose-Escalation Study of AME-133v (LY 2469298), Administered Intravenously in Four Weekly Doses, in Subjects With CD20+ Follicular Relapsed or Refractory Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 80 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in the study protocol, subjects have to meet all of the following criteria.
Have adequate hematopoietic, renal, and hepatic function defined as:
Exclusion Criteria:
Subjects with any of the following exclusions are not allowed to participate in the study.
United States, Alabama | |
University of Alabama Medical Center | |
Birmingham, Alabama, United States, 35249 | |
United States, California | |
UCLA Medical Hematology and Oncology | |
Los Angeles, California, United States, 90095 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Nevada | |
Nevada Cancer Institute | |
Las Vegas, Nevada, United States, 89135 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Brian Link, MD | University of Iowa |
Principal Investigator: | Andres Forero-Torres, MD | University of Alabama Medical Center |
Principal Investigator: | Nam Dang, MD | Nevada Cancer Institute |
Principal Investigator: | Sven de Vos, MD, PhD | University of California, Los Angeles |
Principal Investigator: | Kristen Ganjoo, MD | Stanford University |
Principal Investigator: | Brad Pohlman, MD | The Cleveland Clinic |
Principal Investigator: | Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center |
Principal Investigator: | Michael E. Williams, MD | University of Virginia Health Systems |
Principal Investigator: | Ian Flinn, MD, PhD | Sarah Cannon Research Institute |
Principal Investigator: | Markus Mapara, MD, PhD | University of Pittsburgh |
Principal Investigator: | Stephanie A. Gregory, MD | Rush University Medical Center |
Responsible Party: | Applied Molecular Evolution ( Susan Carpenter/Director Clinical Services ) |
Study ID Numbers: | AME 06.133v.A |
Study First Received: | July 18, 2006 |
Last Updated: | June 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00354926 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma rituximab humanized monoclonal antibody anti-CD20 monoclonal antibody |
Antibodies, Monoclonal Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antibodies Immunoproliferative Disorders Immunologic Factors |
Rituximab Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |