A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal(Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Steroid Refractory Acute GVHD
Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the
United States each year (IBMTR, 2003). Nearly 50% (approximately 3,150) of these patients
develop acute GVHD (Goker et al). A fraction of these patients (approximately 870) will
progress to the severe stages of the disease, Grades III-IV. It is estimated that nearly 82%
of those patients with severe acute GVHD will be steroid refractory (Przepiorka et al.,
1995) and of these, only 50% of steroid-refractory patients wll respond to secondary and
tertiary treatments (Greinix et al., 2000). Thus, roughly 350 patients each year face
tremendous odds against survival. In addition, most patients who initially responded to
secondary and tertiary treatments have a high risk of dying within the first year (Remberger
et al., 2001; Anasetti et al., 1994). Development of new therapeutic agents and strategies
to rescue patients with steroid refractory, acute GVHD would provide a significant benefit
in an area of unmet medical need.
Patients will receive standard of care in addition to adult mesenchymal stem cells or
placebo.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Complete Response of greater than or equal to 28 days duration
Day 100
No
Paul Martin, MD
Principal Investigator
Fred Hutchinson Cancer Center
United States: Food and Drug Administration
280
NCT00366145
July 2006
May 2009
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
Arizona Cancer Center | Tucson, Arizona 85724 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
New York Medical College | Valhalla, New York 10595 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Mount Sinai Medical Center | New York, New York 10029 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
City of Hope | Duarte, California 91010 |
Duke University | Durham, North Carolina 27710 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Baylor University | Waco, Texas |
University of Rochester | Rochester, New York 14642 |
Emory University | Atlanta, Georgia 30322 |
Northwestern Center for Clinical Research | Chicago, Illinois 60611 |
University of Louisville | Louisville, Kentucky 40202 |
University of Miami | Miami, Florida 33136 |
Oregon Health and Science University | Portland, Oregon 97201 |
New York Presbyterian Hospital | New York, New York 10021 |
Texas Cancer Center at Medical City | Dallas, Texas 75230 |
Univeristy of Texas Southwestern Medical Center | Dallas, Texas |
University of Nebraska | Omaha, Nebraska 68198 |
Penn State Hershey Medical Center | Hershey, Pennsylvania 17033 |
Northside Hospital | Atlanta, Georgia 30342 |
Mayo Clinic Rochester | Rochester, Minnesota 55905 |
Tufts-New England Medical Center | Boston, Massachusetts 02111 |
Univeristy of California San Francisco | San Francisco, California 94143 |
Yale New Haven Hospital | New Haven, Connecticut 06520 |
University of Illinois - Chicago | Chicago, Illinois 60612 |
Indiana Blood and Bone Marrow Transplant Center | Beech Grove, Indiana 46107 |
Univeristy of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Maryland/Greenbaum | Baltimore, Maryland 21201 |
Karmanos/Wayne State University | Detroit, Michigan 48201 |
Univeristy of Mississippi Medical Center | Jackson, Mississippi 39216 |
Roswell Park | Buffalo, New York 14263 |
Columbia University/New York Presbyterian Hospital | New York, New York 10032 |
Wake Forest Univeristy School of Medicine | Winston Salem, North Carolina 27157 |
Texas Research Center | San Antonio, Texas 78229 |
Virginia Commonwealth/Massey Cancer Center | Richmond, Virginia 23298 |
University of Wisconsin Madison | Madison, Wisconsin 53792 |