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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00042744 |
RATIONALE: Visilizumab may suppress the immune system and may be an effective treatment for graft-versus-host disease caused by donor peripheral stem cell transplantation.
PURPOSE: Phase II trial to study the effectiveness of visilizumab in treating patients who have graft-versus-host disease following donor peripheral stem cell transplantation that has not responded to previous treatment.
Condition | Intervention | Phase |
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Graft Versus Host Disease |
Drug: visilizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD |
Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive visilizumab (Nuvion) IV for 1-2 doses.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of grade II-IV acute graft-versus-host disease (GVHD) meeting 1 of the following criteria:
Must meet at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
University of Massachusetts Memorial Medical Center - University Campus | |
Worcester, Massachusetts, United States, 01655 | |
United States, Missouri | |
Siteman Cancer Center | |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-3330 | |
United States, New York | |
New York Presbyterian Hospital - Cornell Campus | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6310 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75246 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | James Lowder, MD | PDL BioPharma, Inc. |
Study ID Numbers: | CDR0000069416, PDL-1589 |
Study First Received: | August 5, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00042744 |
Health Authority: | United States: Federal Government |
graft versus host disease |
Antibodies Graft versus host disease Graft vs Host Disease Immunoglobulins Homologous wasting disease |
Immune System Diseases |