RecruitingPhase 3NCT05921305

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

Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease

Sponsor

Peking University People's Hospital

Enrollment

218 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Graft Versus Host Disease

Summary

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Inclusion Criteria8

Patients who are fully informed and sign informed consent by themselves or their guardians;
Patients receiving first allogeneic hematopoietic stem cell transplantation;
Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
KPS>60, Estimated survival >3 months;
No serious organ damage:
ANC in peripheral blood is greater than 0.5×109/l
Creatinine < 1.5mg/dl
Cardiac ejection index > 55%

Exclusion Criteria8

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMTX

MTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR

DRUGCorticosteroid

Corticosteroid Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).