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Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

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.
 
ClinicalTrials.gov Identifier: NCT00045877
Recruitment Status : Completed
First Posted : September 16, 2002
Last Update Posted : February 6, 2006
Sponsor:
Information provided by:
Chiron Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Recombinant Human Interleukin-2 and Rituximab Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
Contacts and Locations
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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): NCT00045877


Locations
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Sponsors and Collaborators
Chiron Corporation
More Information
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ClinicalTrials.gov Identifier: NCT00045877    
Obsolete Identifiers: NCT00066534
Other Study ID Numbers: IL2NHL03
First Posted: September 16, 2002    Key Record Dates
Last Update Posted: February 6, 2006
Last Verified: February 2006
Keywords provided by Chiron Corporation:
Low-Grade or Follicular Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Aldesleukin
Rituximab
Interleukin-2
Antineoplastic Agents, Immunological
 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