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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-65
SponsorPeking University People's Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MTX
  • Corticosteroid

Treatment groups

218 Participants
are divided into 2 treatment groups