Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
This study has been completed.
Information provided by:
First received: September 12, 2002
Last updated: February 2, 2006
Last verified: February 2006
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.
Drug: Recombinant Human Interleukin-2 and Rituximab
||Primary Purpose: Treatment
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045877
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2002
||February 2, 2006
||United States: Food and Drug Administration
Keywords provided by Chiron Corporation:
Low-Grade or Follicular Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Neoplasms by Histologic Type
Immune System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents