NCT Number: NCT00045864
Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
ACRC/Arizona Clinical Research Center, Inc., Tucson, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Chiron Corporation
Industry
Registry information
Important dates
- First posted
- Sep 16, 2002
- Registry last updated
- Feb 6, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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