Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

A Prospective, Multicenter, Open-Label, Phase II Study to Evaluate the Safety and Efficacy of Moxibustion in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: basiliximab, ruxolitinib, methotrexate
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07572669 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label phase II trial conducted at Union Hospital (Wuhan) enrolling 42 patients with steroid-refractory or steroid-dependent grade II–IV acute GVHD predominantly affecting the gastrointestinal tract. All participants receive best available second-line therapy (for example ruxolitinib, basiliximab, or methotrexate) according to clinical judgment, plus moxibustion applied to acupoints ST25 (Tianshu), CV8 (Shenque), and CV6 (Qihai) for 30 minutes once or twice daily for 28 days. The primary outcome is overall response rate at Day 28, with secondary outcomes including durable response at Day 56, incidence and severity of chronic GVHD, and non-relapse mortality. Safety and tolerability of adding moxibustion to standard care will also be monitored.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–65 who had an allogeneic HSCT and now have grade II–IV steroid-refractory or steroid-dependent acute GVHD with gastrointestinal involvement, adequate neutrophil counts, and Traditional Chinese Medicine spleen-kidney yang deficiency pattern.

Not a fit: Patients outside the 14–65 age range, those without predominant GI involvement, those with inadequate neutrophil recovery or contraindications to second-line therapies, pregnant people, or those who do not meet the TCM differentiation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding moxibustion could improve short-term response rates and reduce gastrointestinal symptoms in patients with steroid-refractory acute GVHD.

How similar studies have performed: This application of moxibustion for steroid-refractory aGVHD is largely novel, with only limited or low-quality data for acupuncture/moxibustion in GVHD-related GI symptoms and no large randomized evidence to date.

Eligibility criteria

Inclusion Criteria:

* Participants must meet all of the following criteria:

Age 14 to 65 years, male or female. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). Diagnosis of acute graft-versus-host disease (aGVHD) according to standard criteria, with gastrointestinal involvement (e.g., abdominal pain and diarrhea), and classified as grade II-IV.

Steroid-refractory or steroid-dependent aGVHD, defined as:

Disease progression within 3 days of systemic corticosteroid treatment, or No response within 7 days, or Failure to achieve complete response after 28 days of immunosuppressive therapy, or Recurrence or worsening during steroid tapering. Absolute neutrophil count ≥ 0.5 × 10⁹/L for at least 3 consecutive days. Traditional Chinese medicine (TCM) syndrome differentiation consistent with spleen-kidney yang deficiency.

Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study.

Male participants must agree to use effective contraception during the study. Ability to understand and willingness to sign a written informed consent form. Willingness and ability to comply with study procedures and follow-up.

Exclusion Criteria:

* Participants meeting any of the following criteria will be excluded:

Prior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History of splenectomy after transplantation. Evidence of relapse of the underlying disease 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 human immunodeficiency virus (HIV) infection. Active hepatitis B or C infection requiring treatment, or risk of HBV reactivation.

Receipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer).

Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance \< 40 mL/min.

Hepatic dysfunction unrelated to GVHD, including cholestatic disease or unresolved hepatic veno-occlusive disease.

Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, NYHA class III-IV heart failure, or circulatory failure requiring vasoactive support.

Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support.

Use of high-dose corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) for non-GVHD indications within 7 days prior to enrollment.

Pregnant or breastfeeding women. Severe skin damage or known allergy/intolerance to study-related procedures. Any other condition that, in the investigator's judgment, would interfere with study participation.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: wei MD, PhD

Conditions Steroid-Refractory Acute Graft-Versus-Host Disease; Acute Graft-Versus-Host Disease; Graft-Versus-Host Disease; Allogeneic Hematopoietic Stem Cell Transplantation