Spots Global Cancer Trial Database for Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma
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
Study ID: NCT00354926
Conditions
Interventions
Study Description
Brief Summary: This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Medical Center, Birmingham, Alabama, United States
UCLA Medical Hematology and Oncology, Los Angeles, California, United States
Stanford University Medical Center, Stanford, California, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Contact Details
Name: Brian Link, MD
Affiliation: University of Iowa
Role: PRINCIPAL_INVESTIGATOR
Name: Andres Forero-Torres, MD
Affiliation: University of Alabama Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Nam Dang, MD
Affiliation: Nevada Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Sven de Vos, MD, PhD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Kristen Ganjoo, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
Name: Brad Pohlman, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Mitchell R. Smith, MD, PhD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michael E. Williams, MD
Affiliation: University of Virginia Health Systems
Role: PRINCIPAL_INVESTIGATOR
Name: Ian Flinn, MD, PhD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Markus Mapara, MD, PhD
Affiliation: University of Pittsburgh Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Stephanie A. Gregory, MD
Affiliation: Rush University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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