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Ruxolitinib + Corticosteroids for Grade II Acute GVHD
NCT07340723Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Daihong Liu
- Modality
- Small Molecules
- Drugs
- ruxolitinib
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 2, randomised, open-label trial of ruxolitinib in Acute Graft-Versus-Host Disease (aGvHD) (2 arms), sponsored by Daihong Liu. Primary endpoint: Overall Response Rate at 28 days. Started Jun 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Ruxolitinib Arm
Ruxolitinib 5 mg QD + Methylprednisolone 0.5mg/kg/d
Comparator arm
Methylprednisolone 2mg/kg/d
03
Who it enrols
Patients with hematological diseases who have undergone their first allo-HSCT and developed new-onset grade II or intermediate/high-risk acute GVHD within 100 days post-transplant, without prior first-line aGVHD treatment or prior JAK inhibitor use post-transplant.
04
Endpoints
Primary
Overall Response Rate
Secondary
Duration of Response
Nonrelapse Mortality
Cumulative Incidence of Relapse
Disease-Free Survival
Overall Survival
GVHD-Free and Relapse-Free Survival
Recurrence of acute GVHD
Failure-Free Survival
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