This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T/NK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
This study investigates a novel multi-targeted regimen combining a PD-1 inhibitor, tenofovir, chidamide, and lenalidomide for relapsed/refractory EBV-associated lymphoproliferative disorders (LPDs). Unlike conventional therapies focused on antivirals or chemotherapy alone, this approach integrates antiviral suppression, epigenetic reactivation, immune modulation, and checkpoint blockade to achieve synergistic antitumor and antiviral effects. Preliminary data show effective EBV inhibition and tumor regression. This strategy offers a promising and distinct therapeutic option for EBV-driven lymphoid malignancies resistant to standard treatment.
To evaluate the 3-month overall response rate (ORR), including complete and partial responses, in relapsed/refractory EBV-associated LPD patients treated with PD-1 inhibitor, tenofovir, chidamide, and lenalidomide.
Time frame: 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 Patients achieving CR or PR will continue treatment, while those with SD or PD will be withdrawn from the study.
24-month Overall Survival Rate in Relapsed/Refractory EBV-Associated Lymphoproliferative Disorders.
Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy.
Time frame: From first dose until death from any cause (assessed at 24 months)
24-month Progression-free Survival Rate in Relapsed/Refractory EBV-Associated Lymphoproliferative Disorders.
Proportion of patients without disease progression at 24 months per Lugano 2014 criteria.
Time frame: From first dose until first documented progression or death (assessed at 24 months)
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