Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow
allograft recipients who have at least grade II acute GVHD and who have not achieved a
satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of
methylprednisolone or its equivalent).
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
J. Bruce McClain, M.D.
United States: Food and Drug Administration
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Washington University Medical Center||Saint Louis, Missouri 63105|
|City of Hope National Medical Center||Los Angeles, California 91010|
|Baylor University Medical Center||Dallas, Texas 75246|
|University of Colorado Health Sciences Center||Denver, Colorado 80262|
|M.D. Anderson Cancer Center||Houston, Texas 77030|
|University of Michigan Hospital||Ann Arbor, Michigan 48109|
|University Hospital-University of Oklahoma||Oklahoma City, Oklahoma 73104|
|Western Pennsylvania Hospital - Western Pennsylvania Cancer Center||Pittsburgh, Pennsylvania 15224|
|South Texas Cancer Institute at Methodist Hospital||San Antonio, Texas 78229|