Lymphoma, Non-Hodgkin Clinical Trial
| NCT number | NCT00045864 |
| Other study ID # | IL2NHL05 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | September 12, 2002 |
| Last updated | February 2, 2006 |
| Verified date | February 2006 |
| Source | Chiron Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Cancer Care Center | Bloomington | Indiana |
| United States | Our Lady of Mercy Medical Center, Comprehensive Cancer Center | Bronx | New York |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Northwestern University, Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush Cancer Institute | Chicago | Illinois |
| United States | Oncology Hematology Care Inc. | Cincinnati | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Hematology /Oncology Consultants Inc. | Columbus | Ohio |
| United States | Cancer Specialists of South Texas, P.A. | Corpus Christi | Texas |
| United States | Roger Maris Health System | Fargo | North Dakota |
| United States | Germantown Cancer Center | Germantown | Tennessee |
| United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
| United States | East Carolina University School of Medicine/ Division of Hematology/Oncology | Greenville | North Carolina |
| United States | Kansas City Oncology and Hematology Group | Kansas City | Missouri |
| United States | Dartmouth-Hitchcock-Medical Center | Lebanon | New Hampshire |
| United States | Consultants in Blood Disorders and Cancer | Louisville | Kentucky |
| United States | Division of Hematology/Oncology, University of Miami School of Medicine | Miami | Florida |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Hoag Cancer Center | Newport Beach | California |
| United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Oregon Heath and Science University | Portland | Oregon |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | UC Davis Cancer Center | Sacramento | California |
| United States | John Wayne Cancer Institute | Santa Monica | California |
| United States | Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology | Shreveport | Louisiana |
| United States | Arch Medical Group, LLC | St. Louis | Missouri |
| United States | Stanford University Medical Center | Stanford | California |
| United States | ACRC/Arizona Clinical Research Center, Inc. | Tucson | Arizona |
| United States | Georgetown University Medical Center, Lombardi Cancer Center | Washington | District of Columbia |
| United States | Washington Cancer Institute | Washington | District of Columbia |
| United States | California Cancer Medical Center | West Covina | California |
| Lead Sponsor | Collaborator |
|---|---|
| Chiron Corporation |
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