Expired Study
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Sacramento, California 95817


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.


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).


Study is Available At:


Original ID:

IL2NHL05


NCT ID:

NCT00045864


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Chiron Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:February 2006
Last Changed Date:February 2, 2006
First Received Date:September 12, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Recombinant Human Interleukin-2 and Rituximab

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Chiron Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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