Actively Recruiting
Golidocitinib Combined With Selinexor for the Treatment of Chronic Active Epstein-Barr Virus Disease (CAEBVD): A Multicenter, Prospective, Single-arm Clinical Study
Led by Beijing Friendship Hospital · Updated on 2026-01-27
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment using golidocitinib and selinexor for patients with Chronic Active Epstein-Barr Virus Disease (CAEBVD). This multicenter, prospective, single-arm clinical study aims to assess the effectiveness of this treatment approach. The study is led by Beijing Friendship Hospital and focuses on improving disease activity and viral levels in affected patients. Participants will receive golidocitinib at a dose of 150 mg once daily and selinexor at 40 mg once weekly. This combination therapy is given during the treatment period, with patients monitored closely for response and safety. The study does not include multiple groups or placebo comparison, focusing solely on this experimental treatment. During the study, participants will undergo evaluations of disease activity and Epstein-Barr virus DNA levels eight weeks after starting treatment. Researchers will monitor various health parameters including blood tests and liver and kidney function to ensure safety and treatment adherence. The trial will continue to follow participants until the planned end date, allowing detailed assessment of treatment effects and participant well-being.
CONDITIONS
Brief Title
Golidocitinib Combined With Selinexor for CAEBVD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Chronic Active Epstein-Barr Virus Disease (CAEBVD) according to the 2025 consensus guidelines.
- Aged 18 to 70 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Liver function tests: AST and ALT less than or equal to 3 times the upper limit of normal; total bilirubin less than or equal to 2 times the upper limit of normal.
- Kidney function: serum creatinine less than or equal to 1.5 times the upper limit of normal.
- Blood counts: neutrophil count at least 1 x 10^9/L; platelets at least 50 x 10^9/L; hemoglobin at least 60 g/L.
- Coagulation: INR less than or equal to 2.0; prothrombin time less than or equal to 1.5 times the upper limit of normal.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 12 months after treatment; men must agree to use contraception during and for 6 months after treatment.
- Signed informed consent form.
You will not qualify if you...
- Evidence of EBV-related blood cancers or malignancies such as hemophagocytic lymphohistiocytosis, lymphomatoid granulomatosis, or lymphoma.
- Previous treatment with any JAK inhibitor or investigational drugs within 12 weeks before starting the study treatment.
- Participation in another clinical trial at the same time.
- History of other cancers within 5 years, except certain locally curable skin or bladder cancers.
- History of organ transplantation.
- Planned stem cell transplant during the study.
- Active infections including hepatitis B, hepatitis C, HIV, or syphilis.
- Major surgery within 4 weeks before treatment or planned during the study.
- Pregnant or breastfeeding women.
- Severe mental illness or drug abuse history.
- Uncontrolled infections or major internal bleeding.
- Allergy to study drug components.
- Inability to comply with study or follow-up requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive daily golidocitinib and weekly selinexor as combination therapy for CAEBVD.
Weekly visits for 8 weeks
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jingshi Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1