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

This study has been completed.
Sponsor:
Information provided by:
Chiron Corporation
ClinicalTrials.gov Identifier:
NCT00045864
First received: September 12, 2002
Last updated: February 2, 2006
Last verified: February 2006
  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

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

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

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
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014