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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Event-free survival

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2003

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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