Clinical trial · Interventional
Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.
A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chidamide | — | UNRESOLVED | — |
| Epstein-Barr Virus (EBV) Infection | — | UNRESOLVED | — |
| Lenalidomide | — | UNRESOLVED | — |
| PD-1 Inhibitor | — | UNRESOLVED | — |
| Tenofovir | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Evaluate efficacy and safety of multi-drug therapy in EBV infectious diseases.
- description
- To investigate the therapeutic effect of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in EBV infectious diseases, and to evaluate its safety and clinical benefit in this patient population.
- interventionNames
- Drug: PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases.
Primary outcomes (1)
- measure
- Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), based on EBV-DNA levels.
- timeFrame
- After 3 months of treatment according to the study protocol, a comprehensive efficacy assessment will be conducted. Patients achieving CR or PR will continue treatment, while those with SD or PD will be withdrawn from the study.
Secondary outcomes (2)
- measure
- 24-month overall survival rate of EBV-infected diseases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases; 2. EBV DNA ≥ 10⁴ copies/mL in whole blood or plasma; 3. Age ≤ 75 years with ECOG performance status ≤ 2; 4. Estimated life expectancy over 3 months; 5. 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 Criteria: 1. 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; 2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \<1.5×10⁹/L or platelets \<75×10⁹/L; 3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks; 4. 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); 5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \>1×10⁴ copies/mL) or hepatitis C infection; 6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator; 7. Patients with severe concurrent infections; 8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment; 9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes; 10. Patients deemed unsuitable for enrollment by the investigator; 11. Patients with known hypersensitivity to components of the investigational drug.
References
Publications (0)
Data not yet available