Steroid-Refractory Acute Graft-Versus-Host DiseasePhase 2NCT07572669
Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Moxibustion, Moxibustion Twice Daily Plus Best Available Treatment (BID Group) and Best Available Treatment (BAT) in people with Steroid-Refractory Acute Graft-Versus-Host Disease and Acute Graft-Versus-Host Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Steroid-Refractory Acute Graft-Versus-Host Disease, Acute Graft-Versus-Host Disease, Graft-Versus-Host Disease
- What is being tested?
- Moxibustion, Moxibustion Twice Daily Plus Best Available Treatment (BID Group) and Best Available Treatment (BAT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wei Shi, M.D., +86 027-85726003, shiwei076@hust.edu.cn
About this study
Official title: 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 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.
Read more
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
- Steroid-Refractory Acute Graft-Versus-Host Disease, Acute Graft-Versus-Host Disease, Graft-Versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation
- Being tested
- Moxibustion, Moxibustion Twice Daily Plus Best Available Treatment (BID Group), Best Available Treatment (BAT)
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionProcedure or surgery
Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes once daily for 28 days.
Moxibustion Twice Daily Plus Best Available Treatment (BID Group)Procedure or surgery
Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes twice daily for 28 days.
Best Available Treatment (BAT)Drug
Investigator-selected second-line therapy for SR-aGVHD, including ruxolitinib, basiliximab, or methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion Once Daily Plus Best Available Treatment (QD Group) | Experimental | Not described Receives: Procedure: Moxibustion |
| Moxibustion Twice Daily Plus Best Available Treatment (BID Group) | Experimental | Not described Receives: Procedure: Moxibustion Twice Daily Plus Best Available Treatment (BID Group); Drug: Best Available Treatment (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) at Day 28
Overall response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to established criteria for acute graft-versus-host disease.
Measured: Day 28
Secondary outcomes (5)
Durable Overall Response Rate (ORR) at Day 56
Measured: Day 56
Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)
Incidence and severity of chronic GVHD assessed according to standard clinical criteria.
Measured: Up to 180 days
Non-Relapse Mortality (NRM)
Death without prior relapse of the underlying disease.
Measured: Up to 180 days
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: Up to 180 days
Traditional Chinese Medicine (TCM) Syndrome Score
Changes in TCM syndrome scores based on predefined criteria for spleen-kidney yang deficiency.
Measured: Baseline, Day 14, Day 28, Day 56, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Refractory Acute Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572669
- Sponsor's protocol ID
- [2025]num(0924)
- Status last verified
- Apr 2026
- First submitted
- 3 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07572669
- Acronym / sponsor ID
- [2025]num(0924)
- Conditions
- Steroid-Refractory Acute Graft-Versus-Host Disease, Acute Graft-Versus-Host Disease, Graft-Versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion Once Daily Plus Best Available Treatment (QD Group) | Experimental | Procedure: Moxibustion |
| Moxibustion Twice Daily Plus Best Available Treatment (BID Group) | Experimental | Procedure: Moxibustion Twice Daily Plus Best Available Treatment (BID Group), Drug: Best Available Treatment (BAT) |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxibustionMoxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes once daily for 28 days. | Procedure or surgery | Moxibustion Once Daily Plus Best Available Treatment (QD Group) |
| Moxibustion Twice Daily Plus Best Available Treatment (BID Group)Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes twice daily for 28 days. | Procedure or surgery | Moxibustion Twice Daily Plus Best Available Treatment (BID Group) |
| Best Available Treatment (BAT)Investigator-selected second-line therapy for SR-aGVHD, including ruxolitinib, basiliximab, or methotrexate. | Drug | Moxibustion Twice Daily Plus Best Available Treatment (BID Group) |
Primary outcome
Overall Response Rate (ORR) at Day 28
Time frame: Day 28
Overall response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to established criteria for acute graft-versus-host disease.
5 secondary outcomes
Durable Overall Response Rate (ORR) at Day 56
Time frame: Day 56
Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)
Time frame: Up to 180 days
Non-Relapse Mortality (NRM)
Time frame: Up to 180 days
Overall Survival (OS)
Time frame: Up to 180 days
Traditional Chinese Medicine (TCM) Syndrome Score
Time frame: Baseline, Day 14, Day 28, Day 56, Day 90, Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxibustion, Moxibustion Twice Daily Plus Best Available Treatment (BID Group) and Best Available Treatment (BAT) in people with Steroid-Refractory Acute Graft-Versus-Host Disease and Acute Graft-Versus-Host Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wei MD, PhD (+86 027-85726003, shiwei076@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.