Graft vs Host DiseaseRESCUENCT07184853
Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD
A study testing Ruxolitinib (JAKAVI®) and Etanercept (Enbrel) in people with Graft vs Host Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Ruxolitinib (JAKAVI®) and Etanercept (Enbrel)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 25 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or haploidentical), using bone marrow, peripheral blood stem cells, or cord blood; conditioning regimen may be myeloablative, reduced-intensity, or non-myeloablative.
- Age between 12 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Clinical diagnosis of grade III-IV acute graft-versus-host disease (aGVHD) according to MAGIC criteria.
- Evidence of neutrophil and platelet engraftment prior to study treatment (absolute neutrophil count >1,000/mm³ and platelet count ≥20,000/mm³ within 48 hours before study entry; growth factor support and transfusion permitted).
- Diagnosis of steroid-refractory aGVHD, defined as one of the following:
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- Disease progression after 3-5 days of methylprednisolone 2 mg/kg/day (or equivalent).
- No improvement after 7 days of methylprednisolone 2 mg/kg/day (or equivalent).
- Progression from grade II to grade III-IV aGVHD after 3-5 days of methylprednisolone 1 mg/kg/day (or equivalent).
- Able to take oral medication.
- Expected survival >8 weeks.
- Women of childbearing potential must have a negative serum β-HCG test prior to enrollment; both male and female participants of reproductive potential must agree to use effective contraception during the study and for 3 months after study completion.
- Voluntary written informed consent provided and ability to comply with study procedures.
Who cannot join
- Prior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25 monoclonal antibody is permitted.
- Clinical features consistent with de novo chronic GVHD or overlap syndrome (per Jagasia 2015).
- Uncontrolled active infection, including severe bacterial, fungal, viral, or parasitic infection. Patients on appropriate treatment without evidence of progression may be eligible.
- Evidence of active tuberculosis.
- Known HIV infection.
- Relapse of primary malignancy or post-transplant lymphoproliferative disorder.
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- Severe respiratory disease, including mechanical ventilation or resting oxygen saturation <90%.
- Renal dysfunction: serum creatinine >2.0 mg/dL, requirement for dialysis, or creatinine clearance <30 mL/min (Cockcroft-Gault).
- Active hepatitis B infection (HBsAg positive with HBV DNA ≥1×10³ IU/mL) or active hepatitis C infection (HCV antibody positive with detectable HCV RNA above normal).
- Clinically significant or uncontrolled cardiac disease, including recent myocardial infarction, uncontrolled hypertension, NYHA class III/IV heart failure, unstable angina, or clinically significant arrhythmia (e.g., sustained ventricular tachycardia, second- or third-degree AV block).
- Cholestatic disease or unresolved hepatic veno-occlusive disease not attributed to aGVHD.
- History of progressive multifocal leukoencephalopathy (PML).
- Prior exposure to JAK inhibitors after allo-HSCT.
- Participation in another investigational drug trial within 30 days or within 5 half-lives of the investigational drug (whichever is longer).
- Prior history of grade ≥3 non-hematologic adverse events attributable to ruxolitinib or etanercept.
- Any condition judged by the investigator to place the patient at undue risk or interfere with study participation.
- Known hypersensitivity or intolerance to systemic immunosuppressive agents.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hengwei Wu, 0571 87236562, wuhengwei@zju.edu.cn
About this study
Official title: Prospective Multicenter Randomized Study of Ruxolitinib Plus Etanercept vs Ruxolitinib Alone for Corticosteroid-Refractory Severe Acute GVHD After Allogeneic HSCT
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.
Read more
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.
Read the detailed description
Steroid-refractory severe acute graft-versus-host disease (SR-aGVHD) remains a leading cause of early morbidity and mortality after allogeneic hematopoietic stem cell transplantation. Although ruxolitinib (JAK1/2 inhibition) improves outcomes versus best available therapy, non-response and limited durability-particularly with gastrointestinal involvement-underscore the need for rational combination strategies. Tumor necrosis factor-α (TNF-α) is a proximal driver of allo-inflammation; biomarker analyses suggesting elevated TNFR1 among non-responders to JAK inhibition support TNF-α pathway engagement as a potential mechanism of resistance. Prior single-arm, multicenter experience with ruxolitinib plus etanercept has shown encouraging activity in severe disease, including gastrointestinal and hepatic involvement, without an apparent increase in relapse risk, providing the rationale for this randomized evaluation.
This prospective, multicenter, randomized, open-label study tests whether adding etanercept to ruxolitinib improves clinical response at the prespecified primary assessment time point in patients with corticosteroid-refractory severe aGVHD after allogeneic transplantation. Participants are randomized 1:1 to combination therapy or ruxolitinib alone, with stratification by baseline disease severity to balance key prognostic factors across arms. The open-label design reflects practical differences in administration; where feasible, centralized or blinded review procedures are implemented to mitigate assessment bias.
Study treatment follows protocol-defined principles for initiation, modification, and discontinuation that align with current practice, including management algorithms for cytopenias, organ dysfunction, and relevant drug interactions. Systemic corticosteroids at enrollment are required for the SR definition; tapering after response is guided by predefined algorithms. Concomitant supportive care, infection prophylaxis, and transfusion support are provided according to institutional standards. Rescue therapy or treatment withdrawal is permitted under prespecified lack-of-benefit or safety criteria.
The primary objective is to determine superiority of combination therapy over ruxolitinib alone on clinical response at the primary time point. Key secondary objectives address response durability, transplant-related outcomes, corticosteroid exposure, and safety/tolerability; exploratory analyses include infection burden and biomarker assessments to characterize pharmacodynamic effects and response heterogeneity. Outcome definitions and time frames are specified in the Outcome Measures section; eligibility criteria are provided in the Eligibility section.
Safety is actively monitored throughout treatment and follow-up, with predefined surveillance for infections (including viral reactivation), cytopenias, and organ-specific toxicities. An independent safety review process periodically evaluates unblinded data per charter. The trial is sized to detect a clinically meaningful difference under conservative assumptions and includes longitudinal follow-up to capture durability, survival, and late safety signals, thereby informing whether dual pathway modulation (JAK and TNF-α) can improve outcomes in this high-risk population without unacceptable toxicity.
- Conditions
- Graft vs Host Disease
- Being tested
- Ruxolitinib (JAKAVI®), Etanercept (Enbrel)
- Keywords
- Ruxolitinib, Etanercept, JAK1/2 inhibitor, TNF-α inhibitor, Corticosteroid-refractory GVHD, Severe aGVHD, Allo-HSCT complications, Graft-versus-Host Disease treatment, Immunosuppression
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib (JAKAVI®)Drug
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.
Etanercept (Enbrel)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib Monotherapy | Active comparator | Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food). Treatment will continue for up to 24 weeks. Dose reductions or discontinuation may occur according to protocol-defined safety and response criteria. Corticosteroid tapering will follow study guidelines. Receives: Drug: Ruxolitinib (JAKAVI®) |
| Ruxolitinib Plus Etanercept | Experimental | Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food) combined with etanercept (25 mg subcutaneous injection, twice weekly for 4 weeks, total 8 doses). Etanercept may be extended for an additional 2-4 weeks at investigator's discretion for patients with partial response. Treatment with ruxolitinib may continue for up to 24 weeks, with dose tapering per study protocol. Corticosteroid tapering will follow study guidelines. Receives: Drug: Ruxolitinib (JAKAVI®); Drug: Etanercept (Enbrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) at Day 28
Proportion of patients achieving complete response (CR) or partial response (PR) compared with baseline organ staging, as assessed by MAGIC criteria.
Measured: From date of treatment initiation to Day 28.
Secondary outcomes (10)
Durable Overall Response at Day 56
Proportion of patients who achieved a response at day 28 and maintained the same response at day 56.
Measured: From date of treatment initiation to Day 56.
Duration of Response (DOR)
From first documented response until progression of aGVHD or initiation of new systemic therapy for aGVHD, assessed up to 24 weeks
Measured: From date of treatment initiation to the earliest of loss of response (per MAGIC criteria), initiation of new systemic therapy for aGVHD, or death; assessed up to 24 weeks after treatment initiation.
Best Overall Response (BOR)
Proportion of patients achieving CR or PR at any time up to day 28, without requiring new systemic immunosuppressive therapy.
Measured: From date of treatment initiation through Day 28.
Failure-Free Survival (FFS)
Time from treatment initiation to relapse/progression of underlying hematologic disease, non-relapse mortality, or initiation of new systemic therapy for aGVHD.
Measured: From date of treatment initiation until event, assessed up to 24 weeks.
Overall Survival (OS)
Time from treatment initiation until death from any cause.
Measured: From date of treatment initiation until death, assessed up to 2 years.
Non-Relapse Mortality (NRM)
Death without relapse or progression of underlying hematologic disease.
Measured: From date of treatment initiation until non-relapse death, assessed up to 2 years.
Cumulative Incidence of Relapse (CIR)
Relapse or progression of the underlying hematologic disease.
Measured: From date of treatment initiation until relapse/progression, assessed up to 2 years.
Corticosteroid Use
Assessment of corticosteroid dose reduction and tapering patterns.
Measured: From date of treatment initiation, assessed up to 24 weeks.
Incidence of Chronic GVHD
Cumulative incidence of chronic GVHD or overlap syndrome after study treatment.
Measured: From date of treatment initiation, assessed up to 2 years.
Safety and Tolerability
Incidence, severity, and duration of adverse events (AEs) and serious adverse events (SAEs), including infections and secondary malignancies, assessed according to CTCAE v5.0.
Measured: From treatment initiation until 30 days after the end of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start25 Sep 2025
- Primary completion25 Sep 2027 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified by GVHD grade (III vs IV) and then randomized in a 1:1 ratio to receive either ruxolitinib alone or ruxolitinib plus etanercept.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Children's Hospital of Zhejiang University School of Medicine, Ruijin Hospital
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184853
- Sponsor's protocol ID
- Rux-Eta-SR-aGVHD
- Acronym
- RESCUE
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Study of Ruxolitinib Plus Etanercept vs Ruxolitinib Alone for Corticosteroid-Refractory Severe Acute GVHD After Allogeneic HSCT
- ClinicalTrials.gov ID
- NCT07184853
- Acronym / sponsor ID
- RESCUE / Rux-Eta-SR-aGVHD
- Conditions
- Graft vs Host Disease
- Keywords
- Ruxolitinib, Etanercept, JAK1/2 inhibitor, TNF-α inhibitor, Corticosteroid-refractory GVHD, Severe aGVHD, Allo-HSCT complications, Graft-versus-Host Disease treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Children's Hospital of Zhejiang University School of Medicine, Ruijin Hospital
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Steroid-refractory severe acute graft-versus-host disease (SR-aGVHD) remains a leading cause of early morbidity and mortality after allogeneic hematopoietic stem cell transplantation. Although ruxolitinib (JAK1/2 inhibition) improves outcomes versus best available therapy, non-response and limited durability-particularly with gastrointestinal involvement-underscore the need for rational combination strategies. Tumor necrosis factor-α (TNF-α) is a proximal driver of allo-inflammation; biomarker analyses suggesting elevated TNFR1 among non-responders to JAK inhibition support TNF-α pathway engagement as a potential mechanism of resistance. Prior single-arm, multicenter experience with ruxolitinib plus etanercept has shown encouraging activity in severe disease, including gastrointestinal and hepatic involvement, without an apparent increase in relapse risk, providing the rationale for this randomized evaluation.
This prospective, multicenter, randomized, open-label study tests whether adding etanercept to ruxolitinib improves clinical response at the prespecified primary assessment time point in patients with corticosteroid-refractory severe aGVHD after allogeneic transplantation. Participants are randomized 1:1 to combination therapy or ruxolitinib alone, with stratification by baseline disease severity to balance key prognostic factors across arms. The open-label design reflects practical differences in administration; where feasible, centralized or blinded review procedures are implemented to mitigate assessment bias.
Study treatment follows protocol-defined principles for initiation, modification, and discontinuation that align with current practice, including management algorithms for cytopenias, organ dysfunction, and relevant drug interactions. Systemic corticosteroids at enrollment are required for the SR definition; tapering after response is guided by predefined algorithms. Concomitant supportive care, infection prophylaxis, and transfusion support are provided according to institutional standards. Rescue therapy or treatment withdrawal is permitted under prespecified lack-of-benefit or safety criteria.
The primary objective is to determine superiority of combination therapy over ruxolitinib alone on clinical response at the primary time point. Key secondary objectives address response durability, transplant-related outcomes, corticosteroid exposure, and safety/tolerability; exploratory analyses include infection burden and biomarker assessments to characterize pharmacodynamic effects and response heterogeneity. Outcome definitions and time frames are specified in the Outcome Measures section; eligibility criteria are provided in the Eligibility section.
Safety is actively monitored throughout treatment and follow-up, with predefined surveillance for infections (including viral reactivation), cytopenias, and organ-specific toxicities. An independent safety review process periodically evaluates unblinded data per charter. The trial is sized to detect a clinically meaningful difference under conservative assumptions and includes longitudinal follow-up to capture durability, survival, and late safety signals, thereby informing whether dual pathway modulation (JAK and TNF-α) can improve outcomes in this high-risk population without unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be stratified by GVHD grade (III vs IV) and then randomized in a 1:1 ratio to receive either ruxolitinib alone or ruxolitinib plus etanercept.
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib Monotherapy | Active comparator | Drug: Ruxolitinib (JAKAVI®)Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food). Treatment will continue for up to 24 weeks. Dose reductions or discontinuation may occur according to protocol-defined safety and response criteria. Corticosteroid tapering will follow study guidelines. |
| Ruxolitinib Plus Etanercept | Experimental | Drug: Ruxolitinib (JAKAVI®), Drug: Etanercept (Enbrel)Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food) combined with etanercept (25 mg subcutaneous injection, twice weekly for 4 weeks, total 8 doses). Etanercept may be extended for an additional 2-4 weeks at investigator's discretion for patients with partial response. Treatment with ruxolitinib may continue for up to 24 weeks, with dose tapering per study protocol. Corticosteroid tapering will follow study guidelines. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or haploidentical), using bone marrow, peripheral blood stem cells, or cord blood; conditioning regimen may be myeloablative, reduced-intensity, or non-myeloablative.
- Age between 12 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Clinical diagnosis of grade III-IV acute graft-versus-host disease (aGVHD) according to MAGIC criteria.
- Evidence of neutrophil and platelet engraftment prior to study treatment (absolute neutrophil count >1,000/mm³ and platelet count ≥20,000/mm³ within 48 hours before study entry; growth factor support and transfusion permitted).
Key exclusion criteria (18 listed)
- Prior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25 monoclonal antibody is permitted.
- Clinical features consistent with de novo chronic GVHD or overlap syndrome (per Jagasia 2015).
- Uncontrolled active infection, including severe bacterial, fungal, viral, or parasitic infection. Patients on appropriate treatment without evidence of progression may be eligible.
- Evidence of active tuberculosis.
- Known HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Ruxolitinib Monotherapy, Ruxolitinib Plus Etanercept |
| 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. | Drug | Ruxolitinib Plus Etanercept |
Primary outcome
Overall Response Rate (ORR) at Day 28
Time frame: From date of treatment initiation to Day 28.
Proportion of patients achieving complete response (CR) or partial response (PR) compared with baseline organ staging, as assessed by MAGIC criteria.
10 secondary outcomes
Durable Overall Response at Day 56
Time frame: From date of treatment initiation to Day 56.
Duration of Response (DOR)
Time frame: From date of treatment initiation to the earliest of loss of response (per MAGIC criteria), initiation of new systemic therapy for aGVHD, or death; assessed up to 24 weeks after treatment initiation.
Best Overall Response (BOR)
Time frame: From date of treatment initiation through Day 28.
Failure-Free Survival (FFS)
Time frame: From date of treatment initiation until event, assessed up to 24 weeks.
Overall Survival (OS)
Time frame: From date of treatment initiation until death, assessed up to 2 years.
Non-Relapse Mortality (NRM)
Time frame: From date of treatment initiation until non-relapse death, assessed up to 2 years.
Cumulative Incidence of Relapse (CIR)
Time frame: From date of treatment initiation until relapse/progression, assessed up to 2 years.
Corticosteroid Use
Time frame: From date of treatment initiation, assessed up to 24 weeks.
Incidence of Chronic GVHD
Time frame: From date of treatment initiation, assessed up to 2 years.
Safety and Tolerability
Time frame: From treatment initiation until 30 days after the end of study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib (JAKAVI®) and Etanercept (Enbrel) in people with Graft vs Host Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hengwei Wu, MD (0571 8723 6562, wuhengwei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at Day 28 (time frame: From date of treatment initiation to Day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.