Chidamide as maintenance for HBV-positive diffuse large B‑cell lymphoma after R‑CHOP

Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial

This trial tests whether taking chidamide as maintenance helps adults with HBV-positive diffuse large B‑cell lymphoma who achieved a complete response after R‑CHOP.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT07493109 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 trial enrolls adults (18–80) with CD20‑positive DLBCL and evidence of hepatitis B infection who achieved complete response after six cycles of R‑CHOP and assigns them 1:1 to chidamide maintenance or observation. All participants receive entecavir antiviral therapy per protocol to manage HBV and reduce reactivation risk. The primary endpoint is two‑year progression‑free survival, with secondary endpoints including overall survival, safety, and exploratory biomarkers. The trial will monitor relapse rates, HBV control, and treatment tolerability during follow‑up.

Who should consider this trial

Good fit: Adults aged 18–80 with CD20‑positive DLBCL who are HBsAg positive with detectable HBV DNA and who achieved a complete response after six cycles of R‑CHOP are the intended participants.

Not a fit: Patients who did not achieve a complete response to initial R‑CHOP, who have prior lymphoma treatments, uncontrolled comorbidities, or cannot tolerate antiviral therapy or chidamide are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, chidamide maintenance could reduce relapse and extend progression‑free survival for HBV‑infected DLBCL patients after R‑CHOP.

How similar studies have performed: HDAC inhibitors such as chidamide have shown activity in other lymphomas and chidamide is approved for certain T‑cell lymphomas in China, but randomized evidence for chidamide maintenance in HBV‑infected DLBCL is limited and this application is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Both sexes, age range ≥18 years and ≤80 years.
2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group).
3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (\>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis).
6. Life expectancy of at least 6 months, as judged by the investigator.
7. Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
2. Patients with a history of clinically significant QTc interval prolongation (males \> 450 ms, females \> 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication.
3. Patients who have undergone organ transplantation.
4. Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
5. Patients with active bleeding.
6. Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
7. Patients with active infection, or persistent fever within 14 days before enrollment.
8. Patients who have not completed at least 6 weeks of recovery after major organ surgery.
9. Patients with abnormal liver function (total bilirubin \> 1.5 × upper limit of normal \[ULN\], ALT/AST \> 2.5 × ULN, or \> 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine \> 1.5 × ULN).
10. Patients with mental disorders or those from whom informed consent cannot be obtained.
11. Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
12. Patients with lymphoma involving the central nervous system (CNS).
13. Patients deemed by the investigator to be unsuitable for participation in this study.

Where this trial is running

Changchun, Jilin

• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Ou Bai, PHD — The First Bethune Hospital of Jilin University
• Study coordinator: Ou Bai, PHD

Conditions Diffuse Large B-Cell Lymphoma; HBV-infected DLBCL