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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 MedicineHouston, Texas  77030
MD Anderson Cancer CenterHouston, Texas  77030-4096
Cleveland Clinic FoundationCleveland, Ohio  44195
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
City of Hope National Medical CenterLos Angeles, California  91010
Baylor University Medical CenterDallas, Texas  75246
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Duke UniversityDurham, North Carolina  27710
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University HospitalIndianapolis, Indiana  46202
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
The New York Hospital Cornell Medical CenterNew York, New York  10021
Westchester Medical CenterValhalla, New York  10595
Ohio State UniversityColumbus, Ohio  43210