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Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

NCT07572669 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Moxibustion

Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes once daily for 28 days.

PROCEDURE

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.

DRUG

Best Available Treatment (BAT)

Investigator-selected second-line therapy for SR-aGVHD, including ruxolitinib, basiliximab, or methotrexate.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07572669 on ClinicalTrials.gov