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Compares treatment options for Graft vs Host Disease
Official title Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD
ClinicalTrials.gov ID: NCT07184853
What this study is testing
What is Ruxolitinib (JAKAVI®)?
Ruxolitinib (JAKAVI®) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for graft vs host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or...
- 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...
You likely can't join if
- Prior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25...
- 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...
- Evidence of active tuberculosis.
- Known HIV infection.
- Relapse of primary malignancy or post-transplant lymphoproliferative disorder.
See the full eligibility criteria
- 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...
- 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...
- Diagnosis of steroid-refractory aGVHD, defined as one of the following:
- 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...
- Voluntary written informed consent provided and ability to comply with study procedures.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.