Actively Recruiting
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 14 to 65 years, male or female
- Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Diagnosis of acute graft-versus-host disease (aGVHD) with gastrointestinal involvement, grade II-IV
- Steroid-refractory or steroid-dependent aGVHD as defined by disease progression within 3 days of corticosteroids, no response within 7 days, failure to achieve complete response after 28 days, or recurrence during steroid tapering
- Absolute neutrophil count ≥ 0.5 × 10⁹/L for at least 3 consecutive days
- Traditional Chinese medicine syndrome consistent with spleen-kidney yang deficiency
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use contraception
- Male participants must agree to use effective contraception
- Ability to understand and willingness to sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Prior treatment with one or more systemic therapies for aGVHD other than corticosteroids
- Diagnosis of GVHD overlap syndrome according to NIH criteria
- History of splenectomy after transplantation
- Evidence of relapse or receipt of anti-relapse therapy after transplantation
- Unresolved toxicities or complications from prior transplantation (excluding GVHD)
- 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 or 5 half-lives prior to enrollment
- Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance < 40 mL/min
- Hepatic dysfunction unrelated to GVHD
- Severe cardiovascular disease including unstable angina, recent myocardial infarction, advanced heart failure, or circulatory failure
- Severe respiratory disease requiring mechanical ventilation or ≥ 50% oxygen support
- Use of high-dose corticosteroids for non-GVHD indications within 7 days prior to enrollment
- Pregnant or breastfeeding women
- Severe skin damage or known allergy/intolerance to study procedures
- Any other condition interfering with study participation as judged by investigator
AI-Screening
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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
CONTACT
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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