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NCT Number: NCT07606703

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

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.

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Wuhan, Hubei, 430022, China

Location status: Recruiting

Location contact

Wei Shi, M.D.

CONTACT

[email protected]

+86 027-85726003

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to understand and willingness to sign written informed consent;
  • Age 14 to 65 years;
  • 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;
  • 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;
  • Karnofsky Performance Status (KPS) score ≥60;
  • Absolute neutrophil count >1,000/μL;
  • 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.

Treatment and study plan

Madecassoside Tablets

Drug

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

Drug

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

Primary outcomes

  1. Change in Skin and/or Joint/Fascia NIH cGVHD Scores

    Time frame: 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.

Secondary outcomes

  1. Overall cGVHD Response Rate

    Time frame: 6 months

    Overall response rate of chronic graft-versus-host disease based on the 2014 NIH response criteria.

  2. Failure-Free Survival

    Time frame: 2 years

    Failure-free survival defined as survival without relapse, non-relapse mortality, or addition of new systemic therapy.

  3. Non-Relapse Mortality

    Time frame: 2 years

    Incidence of death without relapse of the underlying disease during follow-up.

  4. Corticosteroid Dose Reduction

    Time frame: 6 months

    Proportion of participants achieving at least 50% reduction or discontinuation of corticosteroid therapy.

  5. Patient-Reported Outcomes

    Time frame: Baseline to 6 months

    Changes in patient-reported outcomes including Lee Symptom Scale (LSS), Scleroderma Health Assessment Questionnaire (SHAQ), and Photographic Range of Motion (P-ROM) scores.

  6. Traditional Chinese Medicine Symptom Score

    Time frame: Baseline to 6 months

    Changes in Traditional Chinese Medicine symptom scores during treatment.

  7. Safety and Adverse Events

    Time frame: Up to 2 years

    Incidence and severity of adverse events assessed according to CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

wei MD, PhD

CONTACT

[email protected]

+86 027-85726003

Sponsors and collaborators

Lead sponsor

WeiShi

Other

Registry information

Official study title

A Prospective, Multicenter, Single-Arm Phase 2 Study of Madecassoside Tablets Combined With Standard Therapy for Sclerotic Chronic Graft-versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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