Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.

February 2, 2006 updated by: Chiron Corporation
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Acrc/Arizona Clinical Research Center, Inc.
    • California
      • Newport Beach, California, United States, 92658
        • Hoag Cancer Center
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Stanford, California, United States, 94305-5151
        • Stanford University Medical Center
      • West Covina, California, United States, 91790
        • California Cancer Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center, Lombardi Cancer Center
    • Florida
      • Miami, Florida, United States, 333136
        • Division of Hematology/Oncology, University of Miami School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Group, LLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock-Medical Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center, Comprehensive Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University School of Medicine/ Division of Hematology/Oncology
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Health System
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care Inc.
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43235
        • Hematology /Oncology Consultants Inc.
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Heath and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Germantown Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialists of South Texas, P.A.
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute

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:

  • Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens.

Exclusion:

  • Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment
  • Clinically significant pulmonary dysfunction.
  • Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment).
  • Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
  • History of autoimmune disease.
  • History of positive serology for human immunodeficiency virus (HIV).

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

Collaborators and Investigators

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

Sponsor

Chiron Corporation

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 Registration Dates

First Submitted

September 12, 2002

First Submitted That Met QC Criteria

September 13, 2002

First Posted (Estimate)

September 16, 2002

Study Record Updates

Last Update Posted (Estimate)

February 6, 2006

Last Update Submitted That Met QC Criteria

February 2, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL2NHL05

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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