NCT07509749

Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)

Prospective Randomized Controlled Trial of Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Daihong Liu · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the severe acute GVHD (graft-versus-host disease )

Detailed description

Acute graft-versus-host disease (GVHD) is treated with systemic corticosteroid immunosuppression as first line therapy. Many patients with severe acute GVHD do not respond to primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of severe acute GVHD.

Conditions

• GVHD, Acute
• Stem Cell Transplant Complications

Interventions

Type	Name	Description
DRUG	Ruxolitinib and Methylprednisolone	Participants began oral administration of ruxolitinib at 5 mg QD; Methylprednisolone (1mg/kg)
DRUG	Methylprednisolone	Methylprednisolone 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China