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Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354926
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Applied Molecular Evolution

Brief Summary:
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Biological: AME-133v (LY2469298) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.
Biological: AME-133v (LY2469298)
IV 4X weekly X 4




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Until the patient is off study (an average of 10 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Absolute neutrophil count greater than 1,500/mm³;
    2. Platelet count greater than 75,000/mm³;
    3. Hemoglobin at least 8 g/dL;
    4. Serum creatinine ≤ 1.5x upper limit of normal;
    5. Total bilirubin ≤ 1.5x upper limit of normal;
    6. ALT ≤ 1.5 x upper limit of normal;
    7. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354926


Locations
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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
Sponsors and Collaborators
Applied Molecular Evolution
Investigators
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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 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Applied Molecular Evolution
ClinicalTrials.gov Identifier: NCT00354926    
Other Study ID Numbers: AME 06.133v.A
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2013
Keywords provided by Applied Molecular Evolution:
Non-Hodgkin's Lymphoma
rituximab
humanized monoclonal antibody
anti-CD20 monoclonal antibody
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases