Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

Study Overview

Status

Status

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

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

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 2
  • 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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • Fullerton, California, United States, 92835
        • Virginia K. Crosson Cancer Center
      • Glendale, California, United States, 91204
        • Pacific Shores Medical Group
      • Glendora, California, United States, 91741
        • Wilshire Oncology Medical Group
      • Greenbrae, California, United States, 94904
        • California Cancer Care Inc.
      • Huntington Beach, California, United States, 92648
        • Pacific Shores Medical Group
      • Lompoc, California, United States, 93438
        • Santa Barbara Hematology Oncology Medical Group
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Los Alamitos, California, United States, 90720
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095
        • UCLS Medical Center
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Mission Hills, California, United States, 91345
        • North Valley Hematology-Oncology Medical Group
      • Newport Beach, California, United States, 92658
        • Hoag Cancer Center
      • Northridge, California, United States, 91328
        • North Valley Hematology/Oncology Medical Group
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Pasadena, California, United States, 91105
        • UCLA Medical Group/Pasadena Oncology
      • Pasadena, California, United States, 91105
        • Wilshire Oncology Medical Group
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Group
      • Poway, California, United States, 92064
        • Southwest Cancer Care
      • Rancho Cucamonga, California, United States, 91730
        • Wilshire Oncology Medical Group
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Meidcal Group, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group, Inc.
      • Santa Barbara, California, United States, 93105
        • Sansum Santa Barbara Foundation Medical Clinic
      • Santa Maria, California, United States, 93454
        • Santa Barbara Hematology Oncology Medical Group
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Solvang, California, United States, 93463
        • Santa Barbara Hematology Oncology Medical Group
      • Torrance, California, United States, 90505
        • Cancer Care Associates Medical Group, Inc.
      • Valencia, California, United States, 91355
        • UCLA/Santa Clarita Valley Cancer Center
      • Ventura, California, United States, 93003
        • Ventura County Hematology-Oncology Specialists
      • Vista, California, United States, 92083
        • San Diego Cancer Center Medical Group
      • West Covina, California, United States, 91790
        • Wilshire Oncology Medical Group
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • Division of Hematology/Oncology, University of Miami, School of Medicine
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical School
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists,S.C.
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Cancer Care Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana Oncology and Hematology Consultants
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Hematology And Oncology Specialists, Llc
      • Shreveport, Louisiana, United States, 71130
        • Louisiana State University Health Sciences Center and VA
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine & Blood Disorders
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Oncology and Hematology Group
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northern New Jersey Cancer Associates
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • New Rochelle, New York, United States, 10801
        • Advanced Oncology Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University/New York Presbyterian Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27858-4354
        • East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Germantown Cancer Foundation
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • 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

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

Diagnosis and disease status:

  • Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded.
  • Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting < 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site.

Exclusion:

  • Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
  • HIV positive.
  • Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
  • Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
  • If cardiac ejection fraction has been measured, it must be greater than 50%.

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

Sponsor

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

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).
September 12, 2002

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.
September 13, 2002

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.
September 16, 2002

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.
February 6, 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.
February 2, 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.
February 1, 2006

More Information

Terms related to this study

Keywords

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.
  • IL2NHL03

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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Conditions

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