Clinical trial NCT00045864: Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Keywords: Intermediate and High-Grade Non-Hodgkin's Lymphoma
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2002-09-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: ACRC/Arizona Clinical Research Center, Inc.
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: West Covina
country: United States
facility: California Cancer Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center, Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Miami
country: United States
facility: Division of Hematology/Oncology, University of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Bloomington
country: United States
facility: Cancer Care Center
state: Indiana
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
state: Louisiana
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Group, LLC
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock-Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center, Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Greenville
country: United States
facility: East Carolina University School of Medicine/ Division of Hematology/Oncology
state: North Carolina
city: Fargo
country: United States
facility: Roger Maris Health System
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc.
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Hematology /Oncology Consultants Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Heath and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Germantown
country: United States
facility: Germantown Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas, P.A.
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
Study officials:
References: