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

StatusRecruiting
PhasePhase 3
Started2023-08-03
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 3, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-05-28
Study Status, Oversight v3
Primary completion date2024-06-30→2026-06-30
Completion date2024-12-31→2026-09-30
2023-10-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-30→confirmed 2023-08-03
Study sites0→2
2023-06-26
Study Identification, Study Status v1
Study title-32 characters
Randomized Trial of Mini-dose MTX Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute GVHD
2023-06-19
Original filing
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.
Trial Details
NCT Number NCT05921305
Lead Sponsor Peking University People's Hospital
Conditions Acute Graft Versus Host Disease
Enrollment 218 participants
Start Date 2023-08-03
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-03