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Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

Primary Purpose

Graft Versus Host Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Prochymal®
Placebo
Standard of Care for GVHD
Sponsored by
Mesoblast, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Acute GVHD, Steroid refractory GVHD, Severe steroid refractory acute GVHD, Steroid refractory, Steroid Refractory Acute Graft Versus Host Disease

Eligibility Criteria

6 Months - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant must be 6 months to 70 years of age, inclusive. Participants who have failed to respond to steroid treatment. Failure to respond to steroid treatment is defined as any grade B-D (IBMTR) grading of acute GVHD that shows: No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent. Participant must be treated within 4 days of randomization. In urgent situations 2nd line therapy may be started 24 hours prior to randomization, and Prochymal® must be initiated within the following 3 days. Participants who have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second line therapy. Participant must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 milliliters per minute (mL/min) using the Cockcroft-Gault equation. For pediatric participants: Schwartz equation: (Participant population: infants over 1 week old through adolescence (<18 years old). 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. Exclusion Criteria: Participant has started treatment with second line therapy >24 hours prior to randomization. Participant has received agents other than steroids for primary treatment of acute GVHD. Participant is participating in the CTN Protocol 0302. 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. Participant may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization. Participant has a known allergy to bovine or porcine products. Participant has received a transplant for a solid tumor disease.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Cancer Center
  • City of Hope
  • Univeristy of California San Francisco
  • Yale New Haven Hospital
  • University of Miami
  • All Children's Hospital
  • Emory University
  • Northside Hospital
  • Northwestern Center for Clinical Research
  • Rush University Medical Center
  • University of Illinois - Chicago
  • Indiana Blood and Bone Marrow Transplant Center
  • Univeristy of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • University of Louisville
  • Louisiana State University
  • University of Maryland/Greenbaum
  • Tufts-New England Medical Center
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Karmanos/Wayne State University
  • Mayo Clinic Rochester
  • Univeristy of Mississippi Medical Center
  • University of Nebraska
  • Hackensack University Medical Center
  • Roswell Park
  • New York Presbyterian Hospital
  • Mount Sinai Medical Center
  • Columbia University/New York Presbyterian Hospital
  • University of Rochester
  • New York Medical College
  • Duke University
  • Wake Forest Univeristy School of Medicine
  • Oregon Health and Science University
  • Penn State Hershey Medical Center
  • Western Pennsylvania Cancer Institute
  • Medical University of South Carolina
  • Texas Cancer Center at Medical City
  • Baylor University
  • Univeristy of Texas Southwestern Medical Center
  • MD Anderson Cancer Center
  • Texas Research Center
  • Virginia Commonwealth/Massey Cancer Center
  • Fred Hutchinson Cancer Research Center
  • University of Wisconsin Madison
  • Medical College of Wisconsin
  • Royal Brisbane Hospital
  • Royal Melbourne Hospital
  • Royal Perth Hospital
  • Co-Medica Research Network
  • British Columbia's Children's Hospital
  • Cancer Care Manitoba
  • Queen Elizabeth II Health Sciences Centre
  • Hamilton Health Sciences Centre
  • London Health Sciences Centre- Westminster Campus
  • Ottawa Hospital
  • Toronto General Hospital
  • Princess Margaret Hospital
  • Maisonneuve-Rosemont Hospital
  • Hopital Enfant-Jesus
  • Hopital du Saint-Sacrement
  • Universia degli Studi di Pesaro
  • IRCCS Policlinico San Matteo
  • Kantonsspital Basel
  • Barts & London School of Medicine
  • John Radcliffe Hospital
  • Bristol Royal Hospital for Children
  • Glasgow Royal Infirmary
  • Leeds General Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prochymal®

Placebo

Arm Description

Participants who receive standard of care plus treatment with ex vivo cultured adult human mesenchymal stem cells.

Participants who receive standard of care and do not receive treatment with ex vivo cultured adult human mesenchymal stem cells.

Outcomes

Primary Outcome Measures

Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days Duration
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response [DCR]) within 100 days post first infusion.

Secondary Outcome Measures

Overall Survival at 180 days Post First Infusion
Percentage of participants who survived at 180 days post first infusion.

Full Information

First Posted
August 17, 2006
Last Updated
February 9, 2022
Sponsor
Mesoblast, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00366145
Brief Title
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
Official Title
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 Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2006 (Actual)
Primary Completion Date
December 26, 2008 (Actual)
Study Completion Date
May 28, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoblast, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
Detailed Description
Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the United States each year (International Bone Marrow Transplant Registry [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 will 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. Participants will receive standard of care in addition to adult mesenchymal stem cells or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
Acute GVHD, Steroid refractory GVHD, Severe steroid refractory acute GVHD, Steroid refractory, Steroid Refractory Acute Graft Versus Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prochymal®
Arm Type
Active Comparator
Arm Description
Participants who receive standard of care plus treatment with ex vivo cultured adult human mesenchymal stem cells.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who receive standard of care and do not receive treatment with ex vivo cultured adult human mesenchymal stem cells.
Intervention Type
Biological
Intervention Name(s)
Prochymal®
Other Intervention Name(s)
Mesenchymal Stem Cells
Intervention Description
2 infusions of 2 million cells/kg per week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
excipients without adult human mesenchymal stem cells
Intervention Description
2 infusions per week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Standard of Care for GVHD
Intervention Description
Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy)
Primary Outcome Measure Information:
Title
Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days Duration
Description
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response [DCR]) within 100 days post first infusion.
Time Frame
up to 100 Days post first infusion
Secondary Outcome Measure Information:
Title
Overall Survival at 180 days Post First Infusion
Description
Percentage of participants who survived at 180 days post first infusion.
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be 6 months to 70 years of age, inclusive. Participants who have failed to respond to steroid treatment. Failure to respond to steroid treatment is defined as any grade B-D (IBMTR) grading of acute GVHD that shows: No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent. Participant must be treated within 4 days of randomization. In urgent situations 2nd line therapy may be started 24 hours prior to randomization, and Prochymal® must be initiated within the following 3 days. Participants who have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second line therapy. Participant must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 milliliters per minute (mL/min) using the Cockcroft-Gault equation. For pediatric participants: Schwartz equation: (Participant population: infants over 1 week old through adolescence (<18 years old). 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. Exclusion Criteria: Participant has started treatment with second line therapy >24 hours prior to randomization. Participant has received agents other than steroids for primary treatment of acute GVHD. Participant is participating in the CTN Protocol 0302. 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. Participant may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization. Participant has a known allergy to bovine or porcine products. Participant has received a transplant for a solid tumor disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher James, PA
Organizational Affiliation
Mesoblast, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Univeristy of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Blood and Bone Marrow Transplant Center
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Univeristy of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University of Maryland/Greenbaum
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Univeristy of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Univeristy School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cancer Center at Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univeristy of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Co-Medica Research Network
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y6J4
Country
Canada
Facility Name
British Columbia's Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H3V4
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0V9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Facility Name
London Health Sciences Centre- Westminster Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4G5
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Enfant-Jesus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Hopital du Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S4L8
Country
Canada
Facility Name
Universia degli Studi di Pesaro
City
Pesaro
State/Province
PU
ZIP/Postal Code
61100
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Kantonsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Barts & London School of Medicine
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 0Du
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
UK
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
UK
ZIP/Postal Code
G4 OSF
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
UK
ZIP/Postal Code
LS1 3EX
Country
United Kingdom

12. IPD Sharing Statement

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PubMed Identifier
11823036
Citation
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Results Reference
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PubMed Identifier
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Citation
Deans RJ, Moseley AB. Mesenchymal stem cells: biology and potential clinical uses. Exp Hematol. 2000 Aug;28(8):875-84. doi: 10.1016/s0301-472x(00)00482-3.
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PubMed Identifier
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Citation
Lazarus HM, Koc ON, Devine SM, Curtin P, Maziarz RT, Holland HK, Shpall EJ, McCarthy P, Atkinson K, Cooper BW, Gerson SL, Laughlin MJ, Loberiza FR Jr, Moseley AB, Bacigalupo A. Cotransplantation of HLA-identical sibling culture-expanded mesenchymal stem cells and hematopoietic stem cells in hematologic malignancy patients. Biol Blood Marrow Transplant. 2005 May;11(5):389-98. doi: 10.1016/j.bbmt.2005.02.001.
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PubMed Identifier
15121408
Citation
Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.
Results Reference
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PubMed Identifier
16040382
Citation
Le Blanc K, Pittenger M. Mesenchymal stem cells: progress toward promise. Cytotherapy. 2005;7(1):36-45. doi: 10.1080/14653240510018118.
Results Reference
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PubMed Identifier
27515308
Citation
Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.
Results Reference
derived
Links:
URL
http://www.osiris.com
Description
Description Click here for more information about this study: A Phase III 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

Learn more about this trial

Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

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