Actively Recruiting
Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-22
122
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized controlled trial designed to evaluate whether the combination of ruxolitinib and etanercept provides superior efficacy compared with ruxolitinib monotherapy in patients with severe corticosteroid-refractory acute graft-versus-host disease (SR-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Acute graft-versus-host disease (aGVHD) is one of the most common and life-threatening complications following allo-HSCT. Although corticosteroids remain the standard first-line treatment, many patients do not respond adequately. For patients with severe steroid-refractory aGVHD, the prognosis is extremely poor, with high short-term mortality and very low long-term survival. Ruxolitinib, a JAK1/2 inhibitor, has been approved for the treatment of SR-aGVHD, but response rates remain suboptimal, particularly in patients with gastrointestinal involvement. Etanercept, a tumor necrosis factor-alpha (TNF-α) inhibitor, has shown activity in GVHD by targeting inflammatory pathways. Previous observational studies from our center suggested that combining ruxolitinib with etanercept may improve response rates, especially in gastrointestinal and hepatic GVHD, without significantly increasing relapse risk. In this trial, approximately 122 patients with grade III-IV SR-aGVHD will be randomized 1:1 to receive either ruxolitinib alone or ruxolitinib plus etanercept. The primary endpoint is the overall response rate (ORR) at day 28. Secondary endpoints include durable response, best overall response, failure-free survival, overall survival, cumulative incidence of relapse, non-relapse mortality, incidence of chronic GVHD, and safety outcomes. This study seeks to provide new clinical evidence for an optimized treatment strategy for patients with severe SR-aGVHD, aiming to improve outcomes in this high-risk population.
CONDITIONS
Official Title
Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received allogeneic hematopoietic stem cell transplantation from any donor source
- Age between 12 and 70 years
- ECOG performance status score of 0 to 2
- Clinical diagnosis of grade III-IV acute graft-versus-host disease according to MAGIC criteria
- Evidence of neutrophil and platelet engraftment before study treatment
- Steroid-refractory acute graft-versus-host disease defined by progression or no improvement after corticosteroid treatment
- Able to take oral medication
- Expected survival longer than 8 weeks
- Women of childbearing potential must have negative pregnancy test before enrollment
- Men and women of reproductive potential must agree to use effective contraception during and for 3 months after the study
- Voluntary written informed consent provided and ability to follow study procedures
You will not qualify if you...
- Prior systemic treatment for acute graft-versus-host disease other than corticosteroids with or without calcineurin inhibitors
- Clinical features of de novo chronic graft-versus-host disease or overlap syndrome
- Uncontrolled active infection or evidence of active tuberculosis
- Known HIV infection
- Relapse of primary malignancy or post-transplant lymphoproliferative disorder
- Severe respiratory disease including mechanical ventilation or low oxygen saturation
- Significant renal dysfunction or requirement for dialysis
- Active hepatitis B or C infection
- Significant or uncontrolled cardiac disease
- Cholestatic disease or unresolved hepatic veno-occlusive disease not due to graft-versus-host disease
- History of progressive multifocal leukoencephalopathy
- Prior exposure to JAK inhibitors after transplant
- Participation in another investigational drug trial recently
- Prior severe adverse events related to ruxolitinib or etanercept
- Any condition posing undue risk or interfering with study participation
- Known hypersensitivity or intolerance to systemic immunosuppressive agents
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
Hengwei Wu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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