NCT00354926

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

July 18, 2006

Last Update Submit

January 5, 2016

Conditions

Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's Lymphomarituximabhumanized monoclonal antibodyanti-CD20 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Until the patient is off study (an average of 10 months)

Study Arms (1)

AME 133v

EXPERIMENTAL

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)

Interventions

AME-133v (LY2469298)BIOLOGICAL

IV 4X weekly X 4

AME 133v

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +6 more criteria

You may not qualify if:

  • Allergy to monoclonal antibodies or any of the study drug components;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama Medical Center

Birmingham, Alabama, 35249, United States

Location

UCLA Medical Hematology and Oncology

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Ganjoo KN, de Vos S, Pohlman BL, Flinn IW, Forero-Torres A, Enas NH, Cronier DM, Dang NH, Foon KA, Carpenter SP, Slapak CA, Link BK, Smith MR, Mapara MY, Wooldridge JE. Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal antibody, in low-affinity FcgammaRIIIa patients with previously treated follicular lymphoma. Leuk Lymphoma. 2015 Jan;56(1):42-8. doi: 10.3109/10428194.2014.911859. Epub 2014 Jul 14.

    PMID: 24717109DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ocaratuzumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 7, 2016

Record last verified: 2013-01

Locations

US(11)