NCT02966301

Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide

Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medsenic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Graft-versus-host disease (GvHD) is the most common long-term complication in patients who underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on immunosuppressive agents (corticosteroids with or without cyclosporine) achieving satisfactory response in around 30% of patients. This is a prospective, national, multicenter, non-randomized Phase II study that will include a total number of 24 patients in which, trioxide d'arsenic will be administrated at 0,15mg/kg/day. Clinical response will be evaluated based on the Working Group Report 2015, published by the National Institute of Health Consensus. Follow-up visits will be weekly for four weeks (ATO cycle), every two weeks from second to third month of ATO treatment, every month from the fourth to sixth month of ATO treatment and every 3 months, at 9 months and 12 months (final visit).

Conditions

• Chronic Graft-Versus-Host Disease
• Immune System Diseases

Interventions

Type	Name	Description
DRUG	Arsenic Trioxide Injectable Solution	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).

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2016-11-17
• Last updated: 2022-05-09
• Results posted: 2022-05-09