A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD
Subjects will be treated with a total of 6 infusions of investigational agent during the
first 4 weeks of the study. Four infusions will be administered during the first two weeks
(twice weekly), then two infusions administered during the next two weeks (once weekly).
Subjects assigned to the active treatment group will receive Prochymal™. Subjects assigned
to the non active treatment group will receive placebo (excipient, less cells). It is
recommended that all subjects receive all six infusions. The discontinuation of
investigational agent is allowed for GVHD worsening with subsequent need for salvage
therapy. All infusions must be given at least 3 days apart.
Subjects will be evaluated for efficacy and safety until death, withdrawal or 90 study days
after randomization, whichever occurs first. Study will be unblinded and data analyzed at
Day 90 post 1st infusion (Day 0)following final subject enrollment. Subjects will be
followed for safety for 12 months post 1st infusion (Day 0).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Achieved an induction of a complete response, Followed by 28 days of maintenance of a clinically meaningful response that does not did not require an increase in corticosteroid dose , did not require second line therapy and survived 90 days.
90 Days
No
Rod L Monroy, Ph.D.
Study Director
Osiris Therapeutics, Inc.
United States: Food and Drug Administration
265
NCT00562497
September 2007
May 2010
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Mount Sinai School of Medicine | New York, New York 10029 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Baylor University Medical Center | Dallas, Texas 75246 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Florida | Gainesville, Florida 32610-0277 |
Tufts New England Medical Center | Boston, Massachusetts 02111 |
Emory University | Atlanta, Georgia 30322 |
Northwestern Center for Clinical Research | Chicago, Illinois 60611 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Ohio State University | Columbus, Ohio 43210 |
University of Louisville | Louisville, Kentucky 40202 |
Texas Transplant Institute | San Antonio, Texas 78229 |
New York Presbyterian Hospital | New York, New York 10021 |
Virginia Commonwealth University | Richmond, Virginia |
Kansas City Cancer Center | Kansas City, Missouri 64111 |
Jewish Hospital | Cincinnati, Ohio 45236 |
Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
University of North Carolina Hospitals | Chapel Hill, North Carolina 27599 |
Northside Hospital | Atlanta, Georgia 30342 |
Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Chicago Hospitals | Chicago, Illinois 60637 |
University of California Medical Center | San Francisco, California 94143 |
University of Alabama Birmingham (UAB) Hospital | Birmingham, Alabama 35249 |
St. Francis Cancer Center | Indianapolis, Indiana 46237 |
Mayo Medical Center | Rochester, Minnesota 55905 |
Duke University Health System | Durham, North Carolina 27705 |
Abramson Cancer Center, University of Pennsylvania Health System | Philadelphia, Pennsylvania 19104 |
University of Pittsburgh Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Oncology Hematology Association | Pittsburgh, Pennsylvania 15232 |
Medical University of South Carolina(MUSC) | Charleston, South Carolina 29425 |