Madecassoside tablets plus standard therapy for sclered scl-cGVHD after allo-HSCT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase 2 trial evaluating the safety and potential efficacy of oral madecassoside tablets in combination with standard therapy for sclerotic chronic graft-versus-host disease following allogeneic hematopoietic stem cell transplantation. Eligible participants are aged 14–65 with NIH-defined scl-cGVHD and a history of limited response to steroids or additional immunosuppressants. Participants will receive madecassoside 0.2 g three times daily alongside their ongoing treatment, with outcomes assessed for response and adverse events. The study aims to determine whether this herbal extract can reduce skin sclerosis, improve joint mobility, and enhance quality of life in this difficult-to-treat population. The trial is sponsored by WeiShi and conducted at Union Hospital in Wuhan, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: wei MD, PhD
• Email: shiwei076@hust.edu.cn
• Phone: +86 027-85726003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belumosudil vs Best Available Therapy for chronic graft-versus-host disease

  In people aged 12 and up with chronic graft-versus-host disease, the study tests belumosudil to see if it works better than the doctor’s choice of best available therapy after prior treatments have failed.

  Recruiting at 3 sites Phase 3 Sanofi · Amsterdam and 2 other locations · NCT07771439

• Mindfulness program to help with symptoms in chronic graft-versus-host disease

  A mindfulness-based program is being tested to see if it can reduce patient-reported symptoms for adults with chronic graft-versus-host disease after a stem cell transplant.

  Recruiting City of Hope Medical Center · Duarte, California · NCT07733141

• Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children

  This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Haikou, Hainan · NCT07725263

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

• Post-transplant dental cleaning to prevent chronic graft-versus-host disease

  This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.

  Recruiting Fred Hutchinson Cancer Center · Seattle, Washington · NCT07535008

• Fatigue and thinking problems after allogeneic stem cell transplant (synapse damage or brain GVHD)

  This project uses PET scans and spinal fluid samples to try to find why people who had an allogeneic stem cell transplant have persistent fatigue and thinking problems.

  Recruiting Karolinska University Hospital · Stockholm · NCT07365696

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.