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

StatusRecruiting
PhasePhase 2
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a prospective, multicenter, open-label, phase II clinical trial designed to evaluate the safety and efficacy of moxibustion in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 42 patients with SR-aGVHD, primarily involving the gastrointestinal tract and presenting with abdominal pain and diarrhea, will be enrolled. All participants will receive standard second-line therapy based on best available treatment (BAT), including ruxolitinib, basiliximab, or methotrexate, according to clinical judgment. In addition, patients will receive moxibustion at specific acupoints (Tianshu \[ST25\], Shenque \[CV8\], and Qihai \[CV6\]) for 30 minutes once or twice daily for 28 days. The primary endpoint is the overall response rate (ORR) at Day 28. Secondary endpoints include durable ORR at Day 56, incidence and severity of chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), and changes in traditional Chinese medicine (TCM) syndrome scores. Safety will be assessed by monitoring adverse events throughout the study period. This study aims to explore whether moxibustion, as an adjunctive therapy, can improve clinical outcomes and provide a safe and effective treatment strategy for patients with SR-aGVHD after allo-HSCT.
Trial Details
NCT Number NCT07572669
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Steroid-Refractory Acute Graft-Versus-Host Disease, Acute Graft-Versus-Host Disease, Graft-Versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov