Mini-dose MTX combined with standard-dose steroids for treating acute GVHD

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 phase III trial is a randomized, open-label study comparing the effectiveness of mini-dose methotrexate (MTX) combined with methylprednisolone to standard-dose methylprednisolone alone in patients with grade 2-4 acute graft-versus-host disease (aGVHD) following allogeneic stem cell transplantation. The study aims to address the limitations of corticosteroid treatment, which has a response rate of approximately 50%, by exploring a combination therapy that may improve patient outcomes. Participants will be monitored for clinical responses and side effects throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who are fully informed and sign informed consent by themselves or their guardians;
2. Patients receiving first allogeneic hematopoietic stem cell transplantation;
3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
4. KPS\>60, Estimated survival \>3 months;
5. No serious organ damage:

   1. ANC in peripheral blood is greater than 0.5×109/l
   2. Creatinine \< 1.5mg/dl
   3. Cardiac ejection index \> 55%

Exclusion Criteria:

1. Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;
2. Patients with uncontrollable active infection;
3. Patients with recurrence of primary malignant hematopathy;
4. Expected survival is less than 3 months
5. Patients who have histories of severe allergic reactions
6. Pregnant or lactating women
7. The researcher judges that there are other factors that are not suitable for participating
8. Patients who received donor lymphocyte infusion

Where it's running

• Peking University Institute of Hematology,
  Beijing, Beijing Municipality, China Recruiting
• Nanfang Hospital, Nanfang Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yu Wang, M.D.
• Email: ywyw3172@sina.com
• Phone: 86-13552647384

Similar studies

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

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• 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

• First-line jaktinib plus corticosteroids for acute graft-versus-host disease

  This trial will test whether adding jaktinib to standard steroids helps adults with grade II–IV acute graft-versus-host disease after an allogeneic stem cell transplant.

  Recruiting Phase 1/2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07285889

• Timing of umbilical cord blood infusion and risk of acute graft-versus-host disease after transplant

  This trial will test whether giving a single-unit unrelated umbilical cord blood transplant at different times of day changes the chance of acute graft-versus-host disease in people with malignant blood disorders who are in remission.

  Recruiting Phase 3 Anhui Provincial Hospital · Hefei, Anhui · NCT07047456

• Ruxolitinib treatment for acute graft-versus-host disease

  This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.

  Recruiting at 10 sites Phase 2 Icahn School of Medicine at Mount Sinai · Duarte, California and 13 other locations · NCT06936566

• Using human chorionic gonadotropin to treat acute graft versus host disease

  This study is testing if adding a hormone called hCG to standard steroid treatment can help people with acute graft versus host disease feel better after their stem cell transplant.

  Recruiting Phase 2 Hospital Universitario Dr. Jose E. Gonzalez · Monterrey, Nuevo León · NCT06904599

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.