Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

Chiron Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: Recombinant Human Interleukin-2 and Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00045877

IL2NHL03

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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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%.