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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00045864
First Posted: September 16, 2002
Last Update Posted: February 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chiron Corporation
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chiron Corporation:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045864


  Show 33 Study Locations
Sponsors and Collaborators
Chiron Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00045864     History of Changes
Other Study ID Numbers: IL2NHL05
First Submitted: September 12, 2002
First Posted: September 16, 2002
Last Update Posted: February 6, 2006
Last Verified: February 2006

Keywords provided by Chiron Corporation:
Intermediate and High-Grade Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Aldesleukin
Rituximab
Interleukin-2
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents