Actively Recruiting
Safety and Efficacy of Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-05-07
42
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 65 years, male or female
- Underwent allogeneic hematopoietic stem cell transplantation
- Diagnosed with acute graft-versus-host disease involving the gastrointestinal tract, graded II-IV
- Steroid-refractory or steroid-dependent acute graft-versus-host disease as defined by disease progression or lack of response to corticosteroids
- Absolute neutrophil count of at least 0.5 x 10^9/L for 3 or more consecutive days
- Traditional Chinese medicine syndrome differentiation consistent with spleen-kidney yang deficiency
- Female participants of childbearing potential must have negative pregnancy test and use effective contraception
- Male participants must agree to use effective contraception
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Prior treatment with more than one systemic therapy for acute graft-versus-host disease besides corticosteroids
- Diagnosis of graft-versus-host disease overlap syndrome
- History of splenectomy after transplantation
- Evidence of relapse or receipt of anti-relapse therapy after transplantation
- Unresolved toxicities or complications from prior transplantation (except graft-versus-host disease)
- Prior moxibustion therapy after transplantation
- Uncontrolled active infection
- Known HIV infection
- Active hepatitis B or C requiring treatment or risk of HBV reactivation
- Receipt of other investigational therapy within 21 days prior to enrollment
- Renal dysfunction with serum creatinine ≥ 2.0 mg/dL or creatinine clearance < 40 mL/min
- Hepatic dysfunction unrelated to graft-versus-host disease
- Severe cardiovascular disease including unstable angina or recent myocardial infarction
- Severe respiratory disease requiring mechanical ventilation or high oxygen support
- Use of high-dose corticosteroids for non-graft-versus-host disease reasons within 7 days prior to enrollment
- Pregnant or breastfeeding women
- Severe skin damage or allergy to study procedures
- Any other condition interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive moxibustion once or twice daily along with best available treatment for steroid-refractory acute graft-versus-host disease for 28 days.
Daily visits or treatment sessions for 28 days
Duration - Up to 180 days
Participants are monitored for treatment response, chronic graft-versus-host disease, survival, and traditional Chinese medicine syndrome scores up to 180 days after treatment.
Visits at Day 14, Day 28, Day 56, Day 90, and Day 180
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
W
wei MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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