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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.

Sponsored by: Chiron Corporation
Information provided by: Chiron Corporation
ClinicalTrials.gov Identifier: NCT00045877
  Purpose

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

MedlinePlus related topics:   Lymphoma   

Drug Information available for:   Aldesleukin    Rituximab    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045877

Show 65 study locations  Show 65 Study Locations

Sponsors and Collaborators
Chiron Corporation
  More Information


Study ID Numbers:   IL2NHL03
First Received:   September 12, 2002
Last Updated:   February 2, 2006
ClinicalTrials.gov Identifier:   NCT00045877
Health Authority:   United States: Food and Drug Administration

Keywords provided by Chiron Corporation:
Low-Grade or Follicular Non-Hodgkin's Lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Aldesleukin
Immunoproliferative Disorders
Interleukin-2
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




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