Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

July 14, 2009

Study Completion Date

May 20, 2010

Conditions
Graft Versus Host Disease
Interventions
DRUG

Prochymal®

Prochymal® intravenous infusion.

OTHER

Placebo

Placebo-matching Prochymal® intravenous infusion.

OTHER

Corticosteroid

Administration will be intravenously as prescribed by the caregiver.

Trial Locations (53)

3050

Royal Melbourne Hospital, Parkville

5000

Royal Adelaide Hospital, Adelaide

6001

Royal Perth Hospital, Perth

10021

Memorial Sloan Kettering Cancer Center, New York

10029

Mount Sinai School of Medicine, New York

10065

New York Presbyterian Hospital, New York

14263

Roswell Park Cancer Institute, Buffalo

15224

Western Pennsylvania Hospital, Pittsburgh

15232

Oncology Hematology Association, Pittsburgh

University of Pittsburgh Cancer Centers, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19104

Abramson Cancer Center, University of Pennsylvania Health System, Philadelphia

19107

Thomas Jefferson University, Philadelphia

23298

Virginia Commonwealth University, Richmond

27157

Wake Forest University School of Medicine, Winston-Salem

27514

University of North Carolina Hospitals, Chapel Hill

27705

Duke University Health System, Durham

29425

Medical University of South Carolina(MUSC), Charleston

30322

Emory University, Atlanta

30342

Northside Hospital, Atlanta

32610

University of Florida, Gainesville

35249

University of Alabama Birmingham (UAB) Hospital, Birmingham

39216

University of Mississippi Medical Center, Jackson

40202

University of Louisville, Louisville

43210

Ohio State University, Columbus

45236

Jewish Hospital, Cincinnati

46202

Indiana University Cancer Center, Indianapolis

46237

St. Francis Cancer Center, Indianapolis

48201

Barbara Ann Karmanos Cancer Institute, Detroit

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Medical Center, Rochester

60153

Loyola University Medical Center, Maywood

60611

Northwestern Center for Clinical Research, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago Hospitals, Chicago

63110

Washington University School of Medicine, St Louis

64064

Kansas City Cancer Center, Lee's Summit

75246

Baylor University Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

78229

Texas Transplant Institute, San Antonio

80218

Rocky Mountain Cancer Center, Denver

90095

UCLA Medical Center, Los Angeles

94143

University of California Medical Center, San Francisco

98109

Fred Hutchinson Cancer Research Center, Seattle

02111

Tufts New England Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

NSW 2010

St. Vincent's Hospital, Darlinghurst

QLD 4029

Royal Brisbane Hospital, Herston

T1Y 6J4

Peter Lougheed Centre, Calgary

K1H 8L6

Ottawa Hospital, Ottawa

M5G 2M9

Princess Margaret Hospital, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mesoblast, Inc.

INDUSTRY