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RECRUITING
NCT05921305
PHASE3

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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

Interventions

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).

Locations (2)

Peking University Institute of Hematology,

Beijing, Beijing Municipality, China

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, China