- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354926
Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma
January 5, 2016 updated by: Applied Molecular Evolution
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
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35249
- University of Alabama Medical Center
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California
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Los Angeles, California, United States, 90095
- UCLA Medical Hematology and Oncology
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Stanford, California, United States, 94305
- Stanford University Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Nevada
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Las Vegas, Nevada, United States, 89135
- Nevada Cancer Institute
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
To be included in the study protocol, subjects have to meet all of the following criteria.
- Have morphologically confirmed diagnosis of CD-20+ follicular B-cell non-Hodgkin's lymphoma;
- Have the low affinity form of FcγRIIIa (F/F or F/V at position 158) as determined by FcR genotyping;
- Have measurable disease. Measurable masses (such as enlarged lymph nodes) must have a clearly defined bi-dimensional diameter of at least 1.5 x 1.5 cm on physical examination or ≤ 1.5 cm in one of the dimensions by CT, MRI, or plain radiograph;
- Have received prior treatment with chemotherapy given without rituximab; OR, Have not relapsed or progressed within 120 days (inclusive) of the last infusion of rituximab;
- Be 18 years of age or greater;
- Have a negative pregnancy test, if relevant. Women of childbearing potential (not postmenopausal for at least one year and not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. To do this, they must agree to use a medically acceptable contraceptive regimen;
- Have a performance status of 0 to 2 on the ECOG performance scale;
Have adequate hematopoietic, renal, and hepatic function defined as:
- Absolute neutrophil count greater than 1,500/mm³;
- Platelet count greater than 75,000/mm³;
- Hemoglobin at least 8 g/dL;
- Serum creatinine ≤ 1.5x upper limit of normal;
- Total bilirubin ≤ 1.5x upper limit of normal;
- ALT ≤ 1.5 x upper limit of normal;
- Alkaline phosphatase ≤ 1.5x upper limit of normal.
- No evidence of hepatitis B or C infection (no detectable HBV DNA or HCV RNA);
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 30 days prior to study enrollment;
- Have discontinued all high-dose corticosteroid therapy at least 30 days prior to study enrollment (≤ 10 mg/day of Prednisone or equivalent is allowable);
- Have life expectancy of more than 3 months;
- Be able to give written informed consent.
Exclusion Criteria:
Subjects with any of the following exclusions are not allowed to participate in the study.
- Allergy to monoclonal antibodies or any of the study drug components;
- Concurrent malignancy that could complicate interpretation of response evaluation, including any histologic evidence of diffuse B-cell lymphoma. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions;
- Significant cardiac disease (e.g. NYHA CHF of class III or IV, history of MI within one year prior to study Day 1, unstable angina, uncontrolled hypertension, clinically significant cardiac arrhythmia (CTCAE Grade 2 or higher), or clinically significant baseline ECG or MUGA abnormality.
- Positive test for serum cardiac troponins (cTnI or cTnT assay; special processing required, and the same assay must be used throughout the study; see Study Reference Manual)
- Active infection requiring oral or i.v. antibiotics;
- Administration of blood transfusions or red blood cell growth factors within 10 days preceding enrollment into the protocol;
- Administration of white cell growth factors within 28 days preceding enrollment into the protocol;
- Concomitant nonmalignant disease(s) which could interfere with implementation of the protocol, make the study results difficult to interpret, or which represent additional safety risks;
- History of HIV-associated non-Hodgkin's lymphoma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AME 133v
All subjects will receive weekly intravenous infusions of AME-133v.
Each subject will receive a total of 4 infusions administered once a week for 3 consecutive weeks.
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IV 4X weekly X 4
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse Events
Time Frame: Until the patient is off study (an average of 10 months)
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Until the patient is off study (an average of 10 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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: 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, SCRI Development Innovations, LLC
- Principal Investigator: Markus Mapara, MD, PhD, University of Pittsburgh Medical Center
- Principal Investigator: Stephanie A. Gregory, MD, Rush University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
July 18, 2006
First Submitted That Met QC Criteria
July 18, 2006
First Posted (Estimate)
July 20, 2006
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 5, 2016
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AME 06.133v.A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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