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

Chiron Corporation

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: Recombinant Human Interleukin-2 and Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00045864

IL2NHL05

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).