Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With 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

To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
• Intervention / Treatment: Drug: Chidamide; Drug: Entecavir Tablets

Detailed Description

Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ou Bai, PHD; Phone Number: 15804302602; Email: oubai16@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Bethune Hospital of Jilin University
      • Contact: Ou Bai, PHD; Phone Number: 15804302602; Email: oubai16@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chidamide group; Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle. Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)	Drug: Chidamide; Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle.; Other Names: HBI-8000; CS055; Tucidinostat
Active Comparator: Control group; Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)	Drug: Entecavir Tablets; Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily); Other Names: ETV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	To assess the Overall Response Rate (ORR) referred to Lugano 2014.	24 months
Overall survival（OS）	Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.	24 months

Collaborators and Investigators

• Sponsor: Ou Bai, MD/PHD
• Investigators: Principal Investigator: Ou Bai, PHD, The First Bethune Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HBV-infected DLBCL
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000; entecavir
• Other Study ID Numbers: HBV-DLBCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No