Status:
NOT_YET_RECRUITING
Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Epstein-Barr Virus (EBV) Infection
PD-1 Inhibitor
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE1
PHASE2
Brief Summary
Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, mu...
Eligibility Criteria
Inclusion
- Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;
- EBV DNA ≥ 10⁴ copies/mL in whole blood or plasma;
- Age ≤ 75 years with ECOG performance status ≤ 2;
- Estimated life expectancy over 3 months;
- Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.
Exclusion
- Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and/or ALT, AST, or serum creatinine \>2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;
- Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \<1.5×10⁹/L or platelets \<75×10⁹/L;
- Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;
- Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) \<50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);
- Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \>1×10⁴ copies/mL) or hepatitis C infection;
- Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
- Patients with severe concurrent infections;
- Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;
- Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;
- Patients deemed unsuitable for enrollment by the investigator;
- Patients with known hypersensitivity to components of the investigational drug.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07133776
Start Date
September 1 2025
End Date
September 1 2027
Last Update
August 21 2025
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