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

NCT ID: NCT00045864

Last Updated: 2006-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Recombinant Human Interleukin-2 and Rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiron Corporation

INDUSTRY

Sponsor Role lead

Locations

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ACRC/Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Site Status

Hoag Cancer Center

Newport Beach, California, United States

Site Status

UC Davis Cancer Center

Sacramento, California, United States

Site Status

John Wayne Cancer Institute

Santa Monica, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

California Cancer Medical Center

West Covina, California, United States

Site Status

Georgetown University Medical Center, Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Site Status

Division of Hematology/Oncology, University of Miami School of Medicine

Miami, Florida, United States

Site Status

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Rush Cancer Institute

Chicago, Illinois, United States

Site Status

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Site Status

Cancer Care Center

Bloomington, Indiana, United States

Site Status

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Site Status

Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology

Shreveport, Louisiana, United States

Site Status

Kansas City Oncology and Hematology Group

Kansas City, Missouri, United States

Site Status

Arch Medical Group, LLC

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock-Medical Center

Lebanon, New Hampshire, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Our Lady of Mercy Medical Center, Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

East Carolina University School of Medicine/ Division of Hematology/Oncology

Greenville, North Carolina, United States

Site Status

Roger Maris Health System

Fargo, North Dakota, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

Oncology Hematology Care Inc.

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Hematology /Oncology Consultants Inc.

Columbus, Ohio, United States

Site Status

Oregon Heath and Science University

Portland, Oregon, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

Germantown Cancer Center

Germantown, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Cancer Specialists of South Texas, P.A.

Corpus Christi, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IL2NHL05

Identifier Type: -

Identifier Source: org_study_id