A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.
The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Washington University Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Baylor Institute of Transplant Sciences
Dallas, Texas, United States
Safety; first infusion of study drug
Time frame: Through Study Day 44
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0.4 mg/kg MEDI 507 and Methylprednisolone
Placebo IV (alternative) study days 0, 3,6, and 9