Phase II Study of Moxibustion Added to Standard Treatment for Steroid-Resistant Acute Graft-Versus-Host Disease After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of moxibustion, a traditional therapy, in patients with steroid-refractory acute graft-versus-host disease SR-aGVHD following allogeneic hematopoietic stem cell transplantation allo-HSCT. This phase II, open-label, multicenter trial focuses on patients primarily experiencing gastrointestinal symptoms such as abdominal pain and diarrhea. The aim is to see if adding moxibustion to standard second-line treatments can improve clinical outcomes and provide a new treatment strategy for SR-aGVHD after allo-HSCT. Participants will receive standard second-line therapy selected by their doctors, which may include drugs like ruxolitinib, basiliximab, or methotrexate. In addition, they will undergo moxibustion treatment applied to specific acupoints Tianshu, Shenque, and Qihai for 30 minutes either once or twice daily over 28 days. The study has two experimental groups one receiving moxibustion once daily plus best available treatment, and the other twice daily plus best available treatment. During the study, participants will be monitored for overall response at Day 28, with additional assessments at Day 56 and up to 180 days for chronic GVHD severity, mortality, survival, and traditional Chinese medicine syndrome scores. Safety will be tracked by recording adverse events throughout. Participants will follow study procedures and attend scheduled evaluations to measure treatment response and health status during and after the 28-day moxibustion period.

Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation