Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD

NARecruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

September 25, 2025

Primary Completion Date

September 25, 2027

Study Completion Date

September 25, 2028

Conditions
Graft vs Host Disease
Interventions
DRUG

Ruxolitinib (JAKAVI®)

Ruxolitinib will be administered orally at a dose of 10 mg twice daily (approximately every 12 hours), with or without food. Dose modifications are allowed according to protocol-defined safety and efficacy criteria. Ruxolitinib may be continued for up to 24 weeks, with tapering guided by patient response and GVHD status.

DRUG

Etanercept (Enbrel)

Etanercept will be administered as a subcutaneous injection at a dose of 25 mg twice weekly for 4 weeks (total 8 doses). For patients with partial response at day 28, treatment may be extended once weekly for an additional 2-4 weeks at the investigator's discretion.

Trial Locations (1)

310000

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

collaborator

Ruijin Hospital

OTHER

lead

First Affiliated Hospital of Zhejiang University

OTHER

NCT07184853 - Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD | Biotech Hunter | Biotech Hunter