Actively Recruiting
First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-12-16
35
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the optimal dose (Recommended Phase 2 Dose, RP2D), preliminary safety, and efficacy of gecacitinib (also known as jaktinib) in combination with glucocorticoids as first-line therapy for patients with grade II-IV acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
CONDITIONS
Official Title
First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent and be 18 years or older at consent
- Received allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood stem cells, or umbilical cord blood
- Received systemic glucocorticoid therapy for no more than 2 days before enrollment
- Have clear myeloid and platelet engraftment: absolute neutrophil count > 1.0 x 10^9/L and platelet count > 50 x 10^9/L (growth factors or transfusions allowed)
- Clinical diagnosis of grade II-IV acute graft-versus-host disease per MAGIC criteria
- ECOG performance status of 0-2
- Life expectancy greater than 4 weeks
- Able to swallow tablets
- Willing and able to follow study procedures and attend follow-up
You will not qualify if you...
- History of two or more allogeneic hematopoietic stem cell transplants
- Acute graft-versus-host disease following unplanned donor lymphocyte infusion for malignancy relapse
- Concurrent treatment with another JAK inhibitor (except if previously stopped due to toxicity)
- Active bleeding
- Diagnosed or suspected chronic graft-versus-host disease
- Uncontrolled active infection causing hemodynamic instability or worsening symptoms
- Unresolved toxicity or complications from transplantation excluding acute GVHD
- Significant medical issues including uncontrolled diabetes (fasting glucose >13.9 mmol/L), hypertension unresponsive to two or more medications, or peripheral neuropathy grade 2 or higher
- Serious heart conditions within 6 months before screening including severe heart failure, unstable angina, heart attack, stroke, or pulmonary embolism
- Arrhythmia needing treatment or prolonged QT interval >480 ms
- Severe kidney impairment (creatinine >1.5 times upper limit of normal)
- History of gastrointestinal surgery affecting drug absorption
- Major surgery within 4 weeks without full recovery
- Liver disorders such as cholestasis or sinusoidal obstruction syndrome
- Active uncontrolled viral infections including hepatitis B or C
- Active tuberculosis within 6 months
- Epilepsy or use of psychotropic or sedative drugs
- Pregnancy, breastfeeding, or intent to conceive; males unwilling to use condoms during treatment and for 2 days after
- Other active cancers within 5 years excluding transplanted hematologic cancer
- Current use of anticoagulants or antiplatelet drugs except low molecular weight heparin
- Any condition judged by investigators to affect safety or compliance
- Known allergy to jaktinib or related compounds
- Participation in another interventional trial within 4 weeks
- Investigator's determination of unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine.
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
YIBO Wu, MD
CONTACT
Y
Yi Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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