A Prospective Study of Madecassoside Tablets in Sclerotic Chronic Graft-versus-Host Disease After Allo-HSCT

NCT07606703 · tracked via the Priya Life Science China tracker

Sponsor

WeiShi

Phase

Phase 2

Started

2025-09-01

Last updated

2026-05-26

Condition(s) studied

Chronic Graft-Versus-Host DiseaseGraft vs Host Disease

Investigational drug(s) / intervention(s)

Madecassoside TabletsStandard Therapy

Madecassoside Tablets: Madecassoside tablets will be administered orally at a dose of 0.2 g (2 tablets) three times daily for 6 months in combination with standard therapy.

Standard Therapy: Standard therapy may include corticosteroids, calcineurin inhibitors, ruxolitinib, belumosudil, topical medications, and supportive care according to institutional guidelines and physician discretion.

Study summary

Sclerotic chronic graft-versus-host disease (scl-cGVHD) is a severe subtype of chronic GVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT), characterized by skin sclerosis, fascial involvement, and restricted joint mobility, leading to substantial functional impairment and reduced quality of life. Current standard therapies, including corticosteroids and other immunosuppressive agents, have limited efficacy in patients with refractory or steroid-dependent disease.

Madecassoside tablets, a standardized extract of Centella asiatica, have demonstrated anti-inflammatory and anti-fibrotic properties in previous studies and may provide therapeutic benefit in fibrotic diseases.

This study is a prospective, multicenter, single-arm phase 2 clinical trial designed to evaluate the efficacy and safety of madecassoside tablets combined with standard therapy in patients with scl-cGVHD after allo-HSCT. Eligible participants will receive oral madecassoside tablets (0.2 g three times daily) in addition to standard treatment for 6 months. Clinical assessments will be performed at baseline and at weeks 4, 8, 12, and 24.

The primary endpoint is the improvement rate of skin and/or joint/fascia NIH cGVHD scores at 6 months according to the 2014 NIH consensus criteria. Secondary endpoints include overall cGVHD response rate, failure-free survival, non-relapse mortality, corticosteroid dose reduction, patient-reported outcomes, and safety assessments. Peripheral blood samples will also be collected to explore changes in inflammatory cytokines and lymphocyte subsets during treatment.

Eligibility

Sex

ALL

Min age

14 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Ability to understand and willingness to sign written informed consent; 2. Age 14 to 65 years; 3. Diagnosis of sclerotic chronic graft-versus-host disease (scl-cGVHD) according to the 2014 NIH consensus criteria, including superficial or deep skin sclerosis, fasciitis, or restricted joint mobility; 4. Prior treatment history meeting at least one of the following: * Received systemic corticosteroid therapy for ≥12 months and at least 1 additional systemic therapy; OR * Received corticosteroid therapy and at least 2 additional systemic therapies; 5. Karnofsky Performance Status (KPS) score ≥60; 6. Absolute neutrophil count \>1,000/μL; 7. Platelet count ≥50,000/μL. Exclusion Criteria: * 1\. Total bilirubin \>1.5 times the upper limit of normal; 2. Creatinine clearance \<30 mL/min; 3. Uncontrolled infection; 4. Uncontrolled cardiovascular or pulmonary disease; 5. Any clinical condition that, in the investigator's judgment, makes the participant unsuitable for study participation.

Primary outcome measure(s)

Change in Skin and/or Joint/Fascia NIH cGVHD Scores — 6 months
The proportion of participants achieving complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) in skin and/or joint/fascia manifestations according to the 2014 NIH chronic graft-versus-host disease response criteria after 6 months of treatment.

Trial sites (1)

Facility	City	Region	Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting

More WeiShi trials in China

Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT. Recruiting

Other trials for the same condition

Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT. Recruiting

Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD Recruiting

Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD Recruiting

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07606703 on ClinicalTrials.gov ↗ ← All trials in China