Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma

September 12, 2013 updated by: Biogen

A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma

To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® [Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL], has in this patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
      • Newport Beach, California, United States, 92658
        • Research Site
      • San Diego, California, United States, 92121
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Tampa Bay, Florida, United States, 33612
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Maywood, Illinois, United States, 60153
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 2115
        • Research Site
    • Michigan
      • Detroit,, Michigan, United States, 48202
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • Research Site
      • New York, New York, United States, 10021
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 1906
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Research Site

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:

  • Signed IRB-approved informed consent
  • Greater than or equal to 18 years of age
  • Proof of follicular lymphoma
  • Progressive disease requiring treatment after at least 1 prior standard therapy
  • Acceptable hematologic status, liver function, and renal function
  • Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment

Exclusion Criteria:

  • No response to prior Rituxan® or Rituxan®-containing regimen
  • Presence of CLL or CNS lymphoma
  • Known history of HIV infection or AIDS
  • Prior diagnosis of aggressive NHL or mantle-cell lymphoma
  • Serious nonmalignant disease
  • Pregnant or currently breast feeding

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: IDEC-114
Dose Group 1 - 125 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions & 375 mg/m2 Rituxan x 4 infusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
Time Frame: March 2010
March 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate PK
Time Frame: March 2010
March 2010
To evaluate efficacy
Time Frame: March 2010
March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
Time Frame: March 2010
March 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

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.

General Publications

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

November 1, 2002

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 1, 2002

First Submitted That Met QC Criteria

November 4, 2002

First Posted (Estimate)

November 5, 2002

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114-21

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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