Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
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
2 other identifiers
interventional
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 9, 2015
June 1, 2015
3.7 years
April 26, 2012
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival at one year after onset of graft versus host disease
One year
Secondary Outcomes (5)
Response at 14 days after commencement of treatment for acute graft versus host disease
14 days
Response at 28 days after commencement of treatment of acute graft versus host disease
28 days
Incidence of severe infection
One year
Disease free survival at one year
One year
Time to treatment failure, requiring salvage therapy
28 days
Study Arms (2)
Mesenchymal stromal cell therapy
EXPERIMENTALMesenchymal stromal cell therapy in addition to corticosteroid therapy
Corticosteroid therapy
ACTIVE COMPARATORInterventions
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Failure to sign informed consent
- Corticosteroid therapy for 72 hours or greater
- ECOG score equal to or greater than 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R.P.Herrmannlead
- Royal Perth Hospitalcollaborator
Study Sites (1)
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duncan Purtill, MB, BS
Royal Perth Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Cell and Tissue Therapies, Royal Perth Hospital
Study Record Dates
First Submitted
April 26, 2012
First Posted
May 2, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
June 9, 2015
Record last verified: 2015-06