Acute Graft Versus Host Disease Clinical Trial
Official title:
Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease
This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to control aGVHD. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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Phase 1/Phase 2 | |
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N/A | |
| Terminated |
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Phase 1 | |
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N/A | |
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Phase 3 | |
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Phase 1 | |
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||
| Recruiting |
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Phase 1 | |
| Recruiting |
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Phase 1 | |
| Not yet recruiting |
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Early Phase 1 | |
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Phase 3 | |
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Phase 3 | |
| Terminated |
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Phase 1/Phase 2 | |
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Phase 1 | |
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Phase 1/Phase 2 | |
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Phase 1/Phase 2 |