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

This study has been completed.

First Received: September 12, 2002 Last Updated: February 2, 2006 History of Changes

Sponsored by:	Chiron Corporation
Information provided by:	Chiron Corporation
ClinicalTrials.gov Identifier:	NCT00045864

Purpose

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.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: Recombinant Human Interleukin-2 and Rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Interleukin-2 Aldesleukin Rituximab

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045864

Show 33 Study Locations

Sponsors and Collaborators

Chiron Corporation

More Information

No publications provided

Study ID Numbers:	IL2NHL05
Study First Received:	September 12, 2002
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00045864 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Chiron Corporation:

Intermediate and High-Grade Non-Hodgkin's Lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Anti-HIV Agents
Rituximab
Antiviral Agents
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Aldesleukin
Anti-Retroviral Agents

Interleukin-2
Analgesics, Non-Narcotic
Analgesics
Peripheral Nervous System Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Aldesleukin

Anti-Retroviral Agents
Sensory System Agents
Analgesics, Non-Narcotic
Interleukin-2
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009