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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00045877
Other study ID # IL2NHL03
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 12, 2002
Last updated February 2, 2006

Study information

Verified date February 2006
Source Chiron Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT00066534

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Recombinant Human Interleukin-2 and Rituximab


Locations

Country Name City State
United States Comprehensive Blood and Cancer Center Bakersfield California
United States Cancer Care Center Bloomington Indiana
United States Erie County Medical Center Buffalo New York
United States Fletcher Allen Health Care Burlington Vermont
United States Gabrail Cancer Center Canton Ohio
United States Northwestern University Medical School Chicago Illinois
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute Columbus Ohio
United States Hematology Oncology Consultants, Inc. Columbus Ohio
United States California Oncology of the Central Valley Fresno California
United States Virginia K. Crosson Cancer Center Fullerton California
United States Germantown Cancer Foundation Germantown Tennessee
United States Pacific Shores Medical Group Glendale California
United States Wilshire Oncology Medical Group Glendora California
United States Benefis Healthcare Great Falls Montana
United States California Cancer Care Inc. Greenbrae California
United States Cancer Centers of the Carolinas Greenville South Carolina
United States East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology Greenville North Carolina
United States Northern New Jersey Cancer Associates Hackensack New Jersey
United States Comprehensive Cancer Centers of Nevada Henderson Nevada
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Pacific Shores Medical Group Huntington Beach California
United States Indiana Oncology and Hematology Consultants Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Kansas City Oncology and Hematology Group Kansas City Missouri
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Santa Barbara Hematology Oncology Medical Group Lompoc California
United States Pacific Shores Medical Group Long Beach California
United States Pacific Shores Medical Group Los Alamitos California
United States UCLS Medical Center Los Angeles California
United States Consultants in Blood Disorders and Cancer Louisville Kentucky
United States Division of Hematology/Oncology, University of Miami, School of Medicine Miami Florida
United States Facey Medical Foundation Mission Hills California
United States North Valley Hematology-Oncology Medical Group Mission Hills California
United States Hematology and Oncology Specialists, LLC New Orleans Louisiana
United States Advanced Oncology Associates New Rochelle New York
United States Mount Sinai School of Medicine New York New York
United States Weill Medical College of Cornell University/New York Presbyterian Hospital New York New York
United States Hoag Cancer Center Newport Beach California
United States North Valley Hematology/Oncology Medical Group Northridge California
United States Whittingham Cancer Center Norwalk Connecticut
United States Ventura County Hematology-Oncology Specialists Oxnard California
United States Oncology Specialists,S.C. Park Ridge Illinois
United States UCLA Medical Group/Pasadena Oncology Pasadena California
United States Wilshire Oncology Medical Group Pasadena California
United States Wilshire Oncology Medical Group Pomona California
United States Oregon Health & Science University Portland Oregon
United States Southwest Cancer Care Poway California
United States Wilshire Oncology Medical Group Rancho Cucamonga California
United States Cancer Care Associates Meidcal Group, Inc. Redondo Beach California
United States Virginia Cancer Institute Richmond Virginia
United States UC Davis Cancer Center Sacramento California
United States Sansum Santa Barbara Foundation Medical Clinic Santa Barbara California
United States Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara California
United States Santa Barbara Hematology Oncology Medical Group Santa Maria California
United States John Wayne Cancer Institute Santa Monica California
United States Maine Center for Cancer Medicine & Blood Disorders Scarborough Maine
United States Louisiana State University Health Sciences Center and VA Shreveport Louisiana
United States Santa Barbara Hematology Oncology Medical Group Solvang California
United States Cancer Care Associates Medical Group, Inc. Torrance California
United States UCLA/Santa Clarita Valley Cancer Center Valencia California
United States Ventura County Hematology-Oncology Specialists Ventura California
United States San Diego Cancer Center Medical Group Vista California
United States Wilshire Oncology Medical Group West Covina California

Sponsors (1)

Lead Sponsor Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States, 

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