Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Eligibility 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%.

Trial Contact Information

Trial Lead Organizations/Sponsors

Chiron Therapeutics

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00045877
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top