Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who develop acute graft-versus-host disease (aGVHD) after receiving a stem cell transplant. The research compares two treatment options: a combination of a low dose of methotrexate (mini-MTX) and a standard dose of steroids (methylprednisolone) against just the standard dose of steroids alone. This trial aims to see if adding mini-MTX can improve outcomes for patients with moderate to severe aGVHD.

To participate in this trial, patients must be adults aged 18 to 75 who have had their first allogeneic stem cell transplant and are diagnosed with grade II-IV aGVHD. They should be generally healthy without major organ damage and expected to live for at least three more months. Participants will receive either the combination treatment or the standard steroid treatment and will be closely monitored for their response to the treatment. This trial is currently recruiting participants, and it’s important for potential candidates to discuss with their healthcare provider to see if they meet the eligibility criteria and if this trial is a good option for them.

Gender

ALL

Eligibility 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