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| ID | Type | Description | Link |
|---|---|---|---|
| CTN 2012/0174 | Other Identifier | Therapeutics Goods Administration, Government of Australia |
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| Name | Class |
|---|---|
| Royal Perth Hospital | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stromal cell therapy | Experimental | Mesenchymal stromal cell therapy in addition to corticosteroid therapy |
|
| Corticosteroid therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stromal cell therapy | Biological | One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival at one year after onset of graft versus host disease | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
Age 18-55 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duncan Purtill, MB, BS | Contact | +61 8 61523788 | duncan.purtill@health.gov.au | |
| Richard Herrmann, MB, BS | Contact | +61 8 92241987 | richard.herrmann@health.wa.gov.au |
| Name | Affiliation | Role |
|---|---|---|
| Duncan Purtill, MB, BS | Royal Perth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| Incidence of severe infection |
| One year |
| Disease free survival at one year | One year |
| Time to treatment failure, requiring salvage therapy | 28 days |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |