NCT05921305

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to control aGVHD.

Conditions

• Acute Graft Versus Host Disease

Interventions

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

Timeline

• Start date: 2023-08-03
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2023-06-27
• Last updated: 2025-06-03

Locations

2 sites across 1 country: China