AzTrials
AzTrials

EBV-Associated Lymphoproliferative DisordersPhase 1/2NCT07133763

Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed/Refractory EBV-associated Lymphoproliferative Disorders.

A Phase 1/2 study testing PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders. in people with EBV-Associated Lymphoproliferative Disorders and PD-1 Inhibitor, run by The Affiliated Hospital of Xuzhou Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). Read more about this study

Who is it for?
Ages 0 to 75 years
What is being tested?
PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 1 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 15Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wei Sang contact

86+13645207648

xyfylbl515@xzhmu.edu.cn

About this study

Official title: A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.

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.

Being tested
PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders.
Keywords
EBV-Associated Lymphoproliferative Disorders, PD-1 Inhibitor, tenofovir, Chidamide, lenalidomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders.Drug

    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.

Study groups in NCT07133763
Study groupRoleWhat they receive
Evaluate efficacy and safety of multi-drug therapy in EBV-Associated Lymphoproliferative Disorders.ExperimentalTo investigate the therapeutic effect of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in EBV-Associated Lymphoproliferative Disorders, and to evaluate its safety and clinical benefit in this patient population.
Receives: Drug: PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  1. 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.

    Measured: From first dose until death from any cause (assessed at 24 months）

  2. 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.

    Measured: From first dose until first documented progression or death (assessed at 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133763
Sponsor's protocol ID
XYFY2025-KL293-01
Status last verified
Aug 2025
First submitted
4 Aug 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders. in people with EBV-Associated Lymphoproliferative Disorders and PD-1 Inhibitor, run by The Affiliated Hospital of Xuzhou Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Sang (86+13645207648, xyfylbl515@xzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in