Back to resultsMesenchymal Stromal Cells for Acute Graft Versus Host Disease
Primary Purpose
Acute GVH Disease
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Mesenchymal stromal cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute GVH Disease focused on measuring Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells
Eligibility Criteria
Inclusion Criteria:
- Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
Age 18-55 years
- Must be receiving a calcineurin inhibitor
Exclusion Criteria:
- Failure to sign informed consent
- Corticosteroid therapy for 72 hours or greater
- ECOG score equal to or greater than 3
Sites / Locations
- Royal Perth HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mesenchymal stromal cell therapy
Corticosteroid therapy
Arm Description
Mesenchymal stromal cell therapy in addition to corticosteroid therapy
Outcomes
Primary Outcome Measures
Survival at one year after onset of graft versus host disease
Secondary Outcome Measures
Response at 14 days after commencement of treatment for acute graft versus host disease
Response at 28 days after commencement of treatment of acute graft versus host disease
Incidence of severe infection
Disease free survival at one year
Time to treatment failure, requiring salvage therapy
Full Information
NCT ID
NCT01589549
First Posted
April 26, 2012
Last Updated
June 8, 2015
Sponsor
R.P.Herrmann
Collaborators
Royal Perth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01589549
Brief Title
Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
Official Title
A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
R.P.Herrmann
Collaborators
Royal Perth Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.
It is hypothesised that mesenchymal stromal cell therapy will be superior
Detailed Description
Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute GVH Disease
Keywords
Acute graft versus host disease, Bone marrow transplantation, Mesenchymal stromal cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stromal cell therapy
Arm Type
Experimental
Arm Description
Mesenchymal stromal cell therapy in addition to corticosteroid therapy
Arm Title
Corticosteroid therapy
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cell therapy
Other Intervention Name(s)
Methylprednisolone, Mesenchymal stem cells
Intervention Description
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Primary Outcome Measure Information:
Title
Survival at one year after onset of graft versus host disease
Time Frame
One year
Secondary Outcome Measure Information:
Title
Response at 14 days after commencement of treatment for acute graft versus host disease
Time Frame
14 days
Title
Response at 28 days after commencement of treatment of acute graft versus host disease
Time Frame
28 days
Title
Incidence of severe infection
Time Frame
One year
Title
Disease free survival at one year
Time Frame
One year
Title
Time to treatment failure, requiring salvage therapy
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
Age 18-55 years
Must be receiving a calcineurin inhibitor
Exclusion Criteria:
Failure to sign informed consent
Corticosteroid therapy for 72 hours or greater
ECOG score equal to or greater than 3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duncan Purtill, MB, BS
Phone
+61 8 61523788
Email
duncan.purtill@health.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Herrmann, MB, BS
Phone
+61 8 92241987
Email
richard.herrmann@health.wa.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan Purtill, MB, BS
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Margaria, BN
Phone
+61 8 92247038
Email
megan.margaria@health.wa.gov.au
12. IPD Sharing Statement
Learn more about this trial
Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
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