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

ConditionsChronic Graft-Versus-Host DiseaseGraft vs Host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorWeiShi

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Received systemic corticosteroid therapy for ≥12 months and at least 1 additional systemic therapy; OR

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental: Madecassoside Tablets Plus Standard TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
6 months

Secondary outcomes

1

Overall cGVHD Response Rate

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

Time frame
6 months
2

Failure-Free Survival

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

Time frame
2 years
3

Non-Relapse Mortality

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

Time frame
2 years
4

Corticosteroid Dose Reduction

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WeiShi

Lead sponsor

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

Sponsor institution

Source ClinicalTrials.gov
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