Evaluating the Safety and Effectiveness of Oral Iguratimod for Treating Chronic Graft-Versus-Host Disease After Stem Cell Transplantation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Iguratimod, a drug used for autoimmune diseases like Sjgrens syndrome, in treating chronic graft-versus-host disease cGVHD after stem cell transplantation. This phase 3, randomized, single-center clinical trial aims to assess Iguratimods potential to reduce inflammation, modulate the immune system, and prevent fibrosis, which are key issues in cGVHD. The study builds on animal research and clinical observations indicating Iguratimods ability to alleviate symptoms common in cGVHD such as dry mouth, dry eyes, and lung fibrosis. Participants receive oral Iguratimod at a dose of 25 mg twice daily. The study focuses on patients who have undergone allogeneic hematopoietic stem cell transplantation and have persistent cGVHD symptoms despite previous treatments. The trial measures safety by monitoring adverse events from the start of treatment through 60 days afterward. Effectiveness is evaluated through responses classified as complete, partial, stable, or progressed disease over the first four months. Throughout the study, participants undergo regular assessments of disease status and side effects. Researchers track changes in symptoms and lung function to understand how Iguratimod affects cGVHD progression. Participants are monitored closely for up to four months to evaluate treatment response, with safety follow-up extending 60 days after treatment. The trial plans to include adults aged 18 to 60 years with stable corticosteroid use and an expected survival of over 12 months.

Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD