Mini-dose MTX combined with standard-dose steroids for treating acute GVHD
Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease
This study is testing if a low dose of methotrexate combined with standard steroids can help people with acute graft-versus-host disease feel better compared to just using the standard steroids alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05921305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone their first allogeneic hematopoietic stem cell transplantation and are diagnosed with grade II-IV acute GVHD.
Not a fit: Patients with severe organ dysfunction, active infections, or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy for patients suffering from acute GVHD, potentially leading to better survival rates and quality of life.
How similar studies have performed: While corticosteroids are the standard treatment for aGVHD, this combination therapy approach has not been previously proven superior, making it a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.