Madecassoside Tablets Combined With Standard Therapy for Sclerotic Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation A Prospective, Multicenter, Single-Arm Phase 2 Study

What this Trial Is About

Researchers are evaluating madecassoside tablets combined with standard therapy for patients who have sclerotic chronic graft-versus-host disease (scl-cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Scl-cGVHD is a serious form of chronic GVHD that causes skin thickening, fascia involvement, and limited joint movement, significantly impacting daily function and quality of life. Current treatments like corticosteroids often have limited success for patients with resistant or steroid-dependent disease. Participants will receive oral madecassoside tablets at a dose of 0.2 g three times daily along with their usual standard therapy, which may include corticosteroids, calcineurin inhibitors, ruxolitinib, belumosudil, topical treatments, and supportive care. This treatment will continue for six months. Clinical assessments will be done at the start and at weeks 4, 8, 12, and 24 during the study. During the study, researchers will monitor changes in skin and joint/fascia conditions using NIH cGVHD scores to assess improvement at 6 months, which is the primary outcome. Secondary outcomes include overall response rates, survival without treatment failure, mortality unrelated to relapse, corticosteroid dose reduction, patient-reported symptoms, safety, and traditional Chinese medicine symptom scores. Blood samples will be collected to study inflammatory markers and immune cells. Safety and adverse events will be tracked for up to two years, with participant involvement lasting through all these assessments.

A Prospective Study of Madecassoside Tablets in Sclerotic Chronic Graft-versus-Host Disease After Allo-HSCT