Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Summary
This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see how well they work compared with standard-dose prednisone or methylprednisolone in treating patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids in treating acute graft-versus-host-disease
Timeline
- Start
- 2009-06
- Primary completion
- 2013-07
- Completion
- 2015-12-14
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Grade IIa GVHD; 0.5 mg/kg/d Prednisone vs Grade IIa GVHD; 1.0 mg/kg/d Prednisone; p = 0.08; t-test, 2 sided NCT00929695 ↗
registry analysis (superiority or other test); Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone vs Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone; p = 0.4; t-test, 2 sided NCT00929695 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 0.5 mg/kg | — |
| Subject | Methylprednisolone | Other / unclassified | 1 mg/kg | — |
| Subject | Methylprednisolone | Other / unclassified | 2 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | — |
| Subject | Prednisone | Other / unclassified | 2 mg/kg | — |