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

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft Versus Host Disease

In brief

This is a Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Prochymal® versus placebo in combination with corticosteroids as initial therapy for acute GVHD. Corticosteroids have been the primary therapy for patients with previously untreated acute GVHD and the historical published data define an expected 35% complete response (CR) at Day +28 using this therapy.

Key facts

Study ID

NCT00562497

Run by

Mesoblast, Inc.

People needed

192

Starts

2008-01-31

Expected to finish

2010-05-20

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be 18 years to 70 years of age, inclusive
• Participants 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.
• Participants 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.
• Participants 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.
• Participants must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 mL/min using the Cockcroft-Gault equation
• Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception
• Participant must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry
• Participant (or legal representative where appropriate) must be capable of providing written informed consent.

You may not qualify if…

• Participant has been previously treated with systemic immunosuppressive therapy for acute GVHD
• Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant including uncontrolled infection, heart failure, pulmonary hypertension, etc.
• Participants 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.
• Participant has a known allergy to bovine or porcine products or dimethyl sulfoxide (DMSO)
• Participant has received a transplant for a solid tumor disease.
• Participant requires more than 2 liters/min of oxygen to maintain stable oxygen saturation (Sa02) greater than or equal to 92%
• Participant 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.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• University of California Medical Center — San Francisco, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• St. Francis Cancer Center — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Medical Center — Rochester, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Kansas City Cancer Center — Lee's Summit, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Alabama Birmingham (UAB) Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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