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).
Interventional
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.
Day 0-60
Yes
J. Bruce McClain, M.D.
Study Director
MedImmune LLC
United States: Food and Drug Administration
MI-CP042
NCT00806728
May 1998
December 1998
Name | Location |
---|---|
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 |