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A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease


Phase 2
N/A
N/A
Open (Enrolling)
Both
Graft-vs-Host Disease

Thank you

Trial Information

A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

1589

NCT ID:

NCT00032279

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Graft-Vs-Host Disease
  • Graft vs Host Disease

Name

Location
Baylor College of Medicine Houston, Texas  77030
MD Anderson Cancer Center Houston, Texas  77030-4096
Cleveland Clinic Foundation Cleveland, Ohio  44195
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Stanford University Medical Center Stanford, California  94305-5408
Washington University School of Medicine Saint Louis, Missouri  63110
City of Hope National Medical Center Los Angeles, California  91010
Baylor University Medical Center Dallas, Texas  75246
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Duke University Durham, North Carolina  27710
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
University Hospital Indianapolis, Indiana  46202
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Medical School Worcester, Massachusetts  01605
The New York Hospital Cornell Medical Center New York, New York  10021
Westchester Medical Center Valhalla, New York  10595
Ohio State University Columbus, Ohio  43210