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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiron Corporation
• Treatments: Aldesleukin; Interleukin-2; Rituximab

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%.