NCT07572669 Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07572669 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Steroid-Refractory Acute Graft-Versus-Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2025-09-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07572669 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Steroid-Refractory Acute Graft-Versus-Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07572669 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07572669 currently recruiting?
Yes, NCT07572669 is actively recruiting participants. Contact the research team at shiwei076@hust.edu.cn for enrollment information.
Where is the NCT07572669 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07572669 clinical trial?
NCT07572669 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 42 participants.