NCT07340723

Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )

Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (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 grade II 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 grade II 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 grade II acute GVHD.

Conditions

• GVHD,Acute
• Stem Cell Transplant Complications

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 0.5mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
DRUG	Corticosteroids	Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: China