Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's Lymphoma

September 8, 2006 updated by: Biogen

A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of the Zevalin Therapeutic Regimen Plus Rituxan Compared With Rituxan Alone in Patients With Relapsed or Refractory Follicular NHL

The purpose of this study is to provide treatment for patients who have relapsed NHL or refractory NHL, and to determine the effectiveness and safety of the Zevalin and Rituxan regimens or Rituxan therapy alone on your disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 3

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
      • Huntsville, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Bakersfield, California, United States
        • Research Site
      • Concord, California, United States
        • Research Site
      • Duarte, California, United States
        • Research Site
      • Loma Linda, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Mission Viejo, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Diego, California, United States, 92121
        • Biogen Idec Incorporated
      • Santa Barbara, California, United States
        • Research Site
      • Vallejo, California, United States
        • Research Site
    • Connecticut
      • Farmington, Connecticut, United States
        • Research Site
    • Delaware
      • Newark, Delaware, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
      • Lakeland, Florida, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
      • Coeur D'Alene, Idaho, United States
        • Research Site
    • Illinois
      • Aurora, Illinois, United States
        • Research Site
      • Chicago, Illinois, United States
        • Research Site
      • Evanston, Illinois, United States
        • Research Site
      • Harvey, Illinois, United States
        • Research Site
      • Maywood, Illinois, United States
        • Research Site
      • Urbana, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
      • Munster, Indiana, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Detroit, Michigan, United States
        • Research Site
      • Flint, Michigan, United States
        • Research Site
      • Royal Oak, Michigan, United States
        • Research Site
      • St. Joseph, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
      • Rochester, Minnesota, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
      • Tupelo, Mississippi, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
      • Farmington, New Mexico, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
      • Buffalo, New York, United States
        • Research Site
      • Manhasset, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Dakota
      • Bismark, North Dakota, United States
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • Temple, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Washington
      • Bremerton, Washington, United States
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Research Site
    • Wisconsin
      • Wausau, Wisconsin, United States
        • 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

Summary of major inclusion and exclusion criteria. Other Safety criteria will need to be met.

Inclusion Criteria:

  • Histologically confirmed, relapsed or refractory CD20+ follicular B-cell NHL within 12 months of Study Day 1 (without clinical evidence of transformation). NHL must require treatment as determined by an increase in overall tumor size. The presence of B symptoms, and/or the presence of masses which are causing ongoing clinical symptoms.
  • Bidimensionally measurable disease meeting the minimum requirement of at least 1 lesion >/= 2.0 cm in a single dimension.
  • No lymphoma therapy for 3 weeks prior to Study Day 1.
  • Patients must be recovered from all toxicities associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy.
  • Signed IRB-approved informed consent.
  • Greater than 18 years of age.
  • Expected survival >/= 3 months.
  • WHO performance status of </= 2.
  • Acceptable hematologic status, liver function, renal function, and pulmonary function.
  • Female patients who are not pregnant or lactating.
  • Men and women of reproductive potential who are following accepted birth control methods.

Exclusion Criteria:

  • Patients with impaired bone marrow reserve, which may be indicated by prior myeloablative therapy with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
  • Prior radioimmunotherapy, including the Zevalin regimen.
  • Prior immunotherapy, including Rituxan therapy within 6 months of Study Day 1.
  • Rituxan-refractory (no response to most recent Rituxan-containing regimen, or TTP was < 6 months).
  • Presence of CNS lymphoma.
  • Patients with chronic lymphocytic leukemia (CLL).
  • Known history of HIV or AIDS.
  • Serious nonmalignant disease or infection
  • Major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
  • Patients who received investigational product within 4 weeks of Study Day 1 or patients who may experience long-term toxicity from a previous investigational therapy.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Event-free survival

Secondary Outcome Measures

Outcome Measure
quality of life
overall survival
time to progression
complete response rate
overall response rate
unconfirmed complete response rate
partial response rate
duration of response
time-to-next anticancer therapy
safety profile

Collaborators and Investigators

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

Sponsor

Biogen

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

March 1, 2003

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

March 31, 2003

First Posted (ESTIMATE)

April 1, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 8, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-10

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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