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.
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;
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
Parallel
MTX
DrugMTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
Corticosteroid
DrugCorticosteroid 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).
Overall response rate (ORR) for aGVHD treatment after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Overall response rate (ORR) for aGVHD treatment at 28 days after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Overall response rate (ORR) for aGVHD treatment at 42 days after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Data collection including questionnaires at individual and group visits and physician interviews at individual visits will be used to assess participants for treatment-related adverse events.
cGVHD
The cumulative incidence of chronic GVHD
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