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

NCT07493109 | Recruiting Phase 3

• 1 other identifier: HBV-DLBCL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

HBV-infected DLBCL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Response Rate (ORR)

  24 months

• Overall survival（OS）

  24 months

Study Arms (2)

Chidamide group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)

Drug: Entecavir Tablets

Interventions

Entecavir Tablets DRUG

Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)

Also known as: ETV

Control group

Chidamide DRUG

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.

Also known as: Tucidinostat, HBI-8000, CS055

Chidamide group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes, age range ≥18 years and ≤80 years.
• 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).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• 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).
• Life expectancy of at least 6 months, as judged by the investigator.
• Understand and voluntarily sign a written informed consent form.

You may not qualify if:

• Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
• 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.
• Patients who have undergone organ transplantation.
• Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
• Patients with active bleeding.
• Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
• Patients with active infection, or persistent fever within 14 days before enrollment.
• Patients who have not completed at least 6 weeks of recovery after major organ surgery.
• 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).
• Patients with mental disorders or those from whom informed consent cannot be obtained.
• Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
• Patients with lymphoma involving the central nervous system (CNS).
• Patients deemed by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• Ou Bai, MD/PHD: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000; entecavir

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ou Bai, PHD

  The First Bethune Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ou Bai, PHD

CONTACT

15804302602; oubai16@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)