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Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Sponsor: Peking University People's Hospital
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.
Official title: Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease
Key Details
Gender
All
Age Range
15 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2023-08-03
Completion Date
2026-09-30
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
MTX
MTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
Corticosteroid
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).
Locations (2)
Peking University Institute of Hematology,
Beijing, Beijing Municipality, China
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong, China