Safety and Efficacy of Iguratimod in the Treatment of Chronic GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
This is a randomized, single-center phase 3 clinical trial without blinding. Iguratimod, as a rheumatoid arthritis medication, is used to treat autoimmune diseases such as Sjögren's syndrome. It has acceptable side effects, good clinical availability, and is cost-effective. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of Iguratimod in the treatment of chronic GVHD.
• Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
• Those with persistent manifestations of chronic graft-versus-host disease (cGVHD) and suitable for systemic treatment.
• Previously received at least 1 but not more than 5 lines of systemic treatment for cGVHD.
• Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose \>0.5mg/kg/day for four weeks, with ongoing cGVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to \>0.25mg/kg/day or an equivalent dose.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\
• Anticipated survival of more than 12 months.
• General criteria:
• Serum pregnancy test negative for women of childbearing age during the screening period.
• Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.