NCT00045864

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2002

Completed
Last Updated

February 6, 2006

Status Verified

February 1, 2006

First QC Date

September 12, 2002

Last Update Submit

February 2, 2006

Conditions

Keywords

Intermediate and High-Grade Non-Hodgkin's Lymphoma

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

ACRC/Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85712, United States

Location

Hoag Cancer Center

Newport Beach, California, 92658, United States

Location

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5151, United States

Location

California Cancer Medical Center

West Covina, California, 91790, United States

Location

Georgetown University Medical Center, Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Division of Hematology/Oncology, University of Miami School of Medicine

Miami, Florida, 333136, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Cancer Care Center

Bloomington, Indiana, 47403, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology

Shreveport, Louisiana, 71130, United States

Location

Kansas City Oncology and Hematology Group

Kansas City, Missouri, 64111, United States

Location

Arch Medical Group, LLC

St Louis, Missouri, 63141, United States

Location

Dartmouth-Hitchcock-Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Our Lady of Mercy Medical Center, Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

East Carolina University School of Medicine/ Division of Hematology/Oncology

Greenville, North Carolina, 27858, United States

Location

Roger Maris Health System

Fargo, North Dakota, 58122, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Oncology Hematology Care Inc.

Cincinnati, Ohio, 45242, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hematology /Oncology Consultants Inc.

Columbus, Ohio, 43235, United States

Location

Oregon Heath and Science University

Portland, Oregon, 97201, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Germantown Cancer Center

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Cancer Specialists of South Texas, P.A.

Corpus Christi, Texas, 78412, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

aldesleukinRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2002

First Posted

September 16, 2002

Last Updated

February 6, 2006

Record last verified: 2006-02

Locations