Status:
NOT_YET_RECRUITING
Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed/Refractory EBV-associated Lymphoproliferative Disorders.
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Conditions:
EBV-Associated Lymphoproliferative Disorders
PD-1 Inhibitor
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Histologically confirmed EBV-associated lymphoproliferative disorders, including EBV-positive B-cell LPD and EBV-positive T/NK-cell LPD, with EBV-encoded RNA (EBER)+ by in situ hybridization, or EBV nuclear antigen (EBNA)+, or latent membrane protein (LMP1/2)+ in the lesion tissue.
- Age ≤75 years with an ECOG performance status ≤2.
- At least one bidimensionally measurable lesion for evaluation: for nodal lesions, longest diameter ≥1.5 cm and shortest diameter ≥1.0 cm; for extranodal lesions, longest diameter ≥1.0 cm; or ≥20% monoclonal EBV-infected lymphocytes detected by flow cytometry.
- Expected survival of more than 3 months.
- Ability to comply with follow-up. Patients must be aware of the nature of their disease and voluntarily agree to participate in the study and follow-up.
Exclusion
- Patients with impaired liver or kidney function, defined as serum direct bilirubin, indirect bilirubin, and/or ALT, AST, or serum creatinine levels \>2 times the upper limit of normal, unless deemed lymphoma-related.
- Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \<1.5×10⁹/L or platelets \<75×10⁹/L, unless the hematologic abnormalities are considered due to bone marrow infiltration by lymphoma.
- Patients who have experienced grade ≥3 neurotoxicity within the past 2 weeks.
- Patients with chronic heart failure classified as NYHA Class III or IV, or with left ventricular ejection fraction \<50%, or with a history within the past 6 months of any of the following: acute coronary syndrome, acute heart failure (Class III or IV), or significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, or post-resuscitation sudden cardiac arrest).
- Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \>1×10⁴ copies/ml) or active hepatitis C infection.
- Patients diagnosed with malignancies other than lymphoma or currently undergoing treatment for other cancers, except:
- ① Those who have received curative treatment and have been disease-free for ≥5 years prior to enrollment;
- ② Patients with adequately treated, non-melanoma skin cancers such as basal cell carcinoma without evidence of disease;
- ③ Patients with adequately treated carcinoma in situ of the cervix without evidence of disease.
- Patients with other hematologic diseases (e.g., hemophilia, myelofibrosis) considered unsuitable for the study by the investigator.
- Patients with severe active infections.
- Patients who underwent Grade 2 or higher surgery within 3 weeks before treatment initiation.
- Patients with a history of substance abuse, or medical, psychological, or social conditions that may interfere with study participation or evaluation, as judged by the investigator.
- Any other condition the investigator considers unsuitable for study enrollment.
- Known hypersensitivity to any component of the investigational drugs.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07133763
Start Date
September 1 2025
End Date
September 1 2027
Last Update
August 21 2025
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