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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


Phase 3
18 Years
70 Years
Not Enrolling
Both
Graft Versus Host Disease

Thank you

Trial Information

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).


Inclusion Criteria:



- Subjects must be 18 years to 70 years of age, inclusive

- Subjects must have received an allogeneic hematopoietic stem cell transplant using
either bone marrow, peripheral blood stem cells or cord blood or administered a donor
leukocyte infusion.

- Subjects must have newly diagnosed Grades B-D acute GVHD. Biopsy confirmation of GVHD
is strongly recommended but not required. Randomization should not be delayed
awaiting biopsy or pathology results.

- Subjects must be randomized and treated with corticosteroid (1-2 mg/kg/d
methylprednisolone, or equivalent) and Prochymal™/placebo within 72 hours of onset of
acute GVHD.

- Subjects must have adequate renal function as defined by: Calculated Creatinine
Clearance of >30mL/min using the Cockroft-Gault equation

- Subjects who are women of childbearing potential, must be non-pregnant, not
breast-feeding, and use adequate contraception. Male subjects must use adequate
contraception

- Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of
study entry

- Subject (or legal representative where appropriate) must be capable of providing
written informed consent.

Exclusion Criteria:

- Subject has been previously treated with systemic immunosuppressive therapy for acute
GVHD

- Subject has any underlying or current medical or psychiatric condition that, in the
opinion of the Investigator, would interfere with the evaluation of the subject
including uncontrolled infection, heart failure, pulmonary hypertension, etc.

- Subjects may not receive any other investigational agents (not approved by the FDA
for any indication) concurrently during study participation or within 30 days of
randomization.

- Subject has a known allergy to bovine or porcine products or DMSO

- Subject has received a transplant for a solid tumor disease.

- Subject requires more than 2L/min of oxygen to maintain stable SaO2 greater than or
equal to 92%

- Subject requires a renal dopamine dose greater than 1-3 mcg/kg/min to maintain renal
blood flow associated with renal failure and improved urinary output.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

90 Days

Safety Issue:

No

Principal Investigator

Rod L Monroy, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Osiris Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

265

NCT ID:

NCT00562497

Start Date:

September 2007

Completion Date:

May 2010

Related Keywords:

  • Graft Versus Host Disease
  • Acute GVHD
  • Acute Graft Versus Host Disease
  • Graft vs Host Disease

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Mount Sinai School of MedicineNew York, New York  10029
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
Medical College of WisconsinMilwaukee, Wisconsin  53226
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Rush University Medical CenterChicago, Illinois  60612-3824
Rocky Mountain Cancer CenterDenver, Colorado  80218
Baylor University Medical CenterDallas, Texas  75246
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of FloridaGainesville, Florida  32610-0277
Tufts New England Medical CenterBoston, Massachusetts  02111
Emory UniversityAtlanta, Georgia  30322
Northwestern Center for Clinical ResearchChicago, Illinois  60611
UCLA Medical CenterLos Angeles, California  90095-7059
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Ohio State UniversityColumbus, Ohio  43210
University of LouisvilleLouisville, Kentucky  40202
Texas Transplant InstituteSan Antonio, Texas  78229
New York Presbyterian HospitalNew York, New York  10021
Virginia Commonwealth UniversityRichmond, Virginia  
Kansas City Cancer CenterKansas City, Missouri  64111
Jewish HospitalCincinnati, Ohio  45236
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
University of North Carolina HospitalsChapel Hill, North Carolina  27599
Northside HospitalAtlanta, Georgia  30342
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
University of Chicago HospitalsChicago, Illinois  60637
University of California Medical CenterSan Francisco, California  94143
University of Alabama Birmingham (UAB) HospitalBirmingham, Alabama  35249
St. Francis Cancer CenterIndianapolis, Indiana  46237
Mayo Medical CenterRochester, Minnesota  55905
Duke University Health SystemDurham, North Carolina  27705
Abramson Cancer Center, University of Pennsylvania Health SystemPhiladelphia, Pennsylvania  19104
University of Pittsburgh Cancer CentersPittsburgh, Pennsylvania  15232
Oncology Hematology AssociationPittsburgh, Pennsylvania  15232
Medical University of South Carolina(MUSC)Charleston, South Carolina  29425