At a glance
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Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide
In Brief
A Phase 2 clinical trial evaluating Arsenic Trioxide Injectable Solution for Chronic Graft-Versus-Host Disease and Immune System Diseases. Completed, enrolled 21 participants.
Detailed Summary
This study aims to evaluate the early chronic GvHD events (first line therapy), if the addition of arsenic trioxide to standard therapy with corticosteroids, with or without cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of corticosteroid therapy
Study Details
Timeline
Interventions
Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle). Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy. The study duration will be 2 years (12 months recruitment + 12 months follow-up).