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COMPLETEDPHASE1

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

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

NCT00354926•Applied Molecular Evolution

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+11 more criteria

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.

Locations (11)

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

Key Dates

Start Date

July 1, 2006

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

January 7, 2016

Enrollment

ACTUAL participants

Conditions

Non-Hodgkin's Lymphoma

Interventions

AME-133v (LY2469298)

BIOLOGICAL

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

NCT06667687

Non-Hodgkin's Lymphoma

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RECRUITINGPHASE1/PHASE2

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT05623982

Non-hodgkin's Lymphoma

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RECRUITINGPHASE2

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation