The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Condition	Treatment or Intervention	Phase
Graft-vs-Host Disease	Drug: Visilizumab	Phase II

Further Study Details: 

Expected Total Enrollment:  80

Genders Eligible for Study:  Both

Criteria

• Grade II to IV GVHD
• Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
• History of allogeneic hematopoietic cell transplant (HCT).
• Patients must have failed to respond or clearly progress to previous therapy on or before day +100 posttransplant.
• Patients must have adequate renal, hepatic, cardiac function and hematologic values

California
      Stanford University Medical Center, Stanford,  California,  94305-5623,  United States
      City of Hope National Medical Center, Duarte,  California,  91910,  United States
Florida
      H. Lee Moffitt Cancer Center & Research Institute, Tampa,  Florida,  33612,  United States
Indiana
      University Hospital, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      University of Massachusetts Medical School, Worcester,  Massachusetts,  01605,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
New York
      The New York Hospital Cornell Medical Center, New York,  New York,  10021,  United States
      Westchester Medical Center, Valhalla,  New York,  10595,  United States
North Carolina
      Duke University, Durham,  North Carolina,  27705,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232-6310,  United States
Texas
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study ID Numbers:  1589
Record last reviewed:  October 2003
Last Updated:  October 25, 2004
Record first received:  March 14, 2002
ClinicalTrials.gov Identifier:  NCT00032279
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08