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A Phase I/II, Open-Label, Dose-Escalation, Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Graft vs Host Disease

Thank you

Trial Information

A Phase I/II, Open-Label, Dose-Escalation, Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation


A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety,
pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line
therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is
anticipated that up to 34 patients at up to 10 study centers could be eligible for
enrollment in this study. Patients will be eligible for enrollment within 24 hours of
beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg
hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following
visilizumab administration.

Inclusion Criteria


- Patients who develop Grade II, III, or IV acute GVHD following allogeneic
hematopoietic cell transplantation

- Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus

- Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.

- Patients with an onset date of acute GVHD that is less than or equal to 100 days
posttransplant.

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:

291-405

NCT ID:

NCT00032292

Start Date:

March 2002

Completion Date:

August 2006

Related Keywords:

  • Graft Vs Host Disease
  • Graft vs Host Disease

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
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
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Duke UniversityDurham, North Carolina  27710