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Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study
This phase II trial studies how well methylprednisolone sodium succinate works in treating patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces inflammation. Giving corticosteroid drugs, such as methylprednisolone sodium succinate, directly into the arteries of the gastrointestinal tract may help treat inflammation caused by GVHD. Giving methylprednisolone sodium succinate in addition to standard treatments may be more effective in treating GVHD.
Details
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2015-10 |
| Completion | 2016-07 |
Conditions
- Acute Graft Versus Host Disease
- Intestinal Graft Versus Host Disease
Interventions
- Budesonide
- Methylprednisolone Sodium Succinate
Primary outcomes
- Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence — Day 56
- Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence — By day 180
- Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence — By day 360
- Proportions of response among surviving patients — Day 14
- Proportions of progression among surviving patients — Day 14
- Rate of acute (and/or chronic) GvHD-free survival — Day 56
Simon's two-stage design will be used. The null hypothesis that the true CR rate is 30% will be tested against a one-sided alternative and presented with a 95% confidence interval.
Countries
United States