Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma

A phase II，single arm，open-label study to assess Maintenance Therapy of Chidamide in Patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma with complete response after completion of prior chemotherapy

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: Tucidinostat

Detailed Description

Objective to evaluate the efficacy and safety of maintenance therapy with Chidamide in patients With Hepatitis B Virus（HBV）Positive Diffuse Large B-cell Lymphoma（DLBCL） with complete response after completion of prior chemotherapy, so as to provide the basis for the application of Chidamide in HBV positive DLBCL

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• histopathology confirmed DLBCL，with chronic hepatitis B before treatment
• After systemic treatment, complete response has been achieved and complete response lasted within 1year before enrollment
• The expected chemotherapy was completed and the laboratory indexes returned to normal
• The absolute value of neutrophil ≥ 1.5 × 10 9 / L, platelet count≥ 90 × 10 9 / L, hemoglobin level≥ 90 g / L
• Patients who cannot undergo hematopoietic stem cell transplantation for various reasons
• 18-75 years old, both male and female
• ECOG PS 0-1
• Body weight: male 67 ± 20 kg (47-87 kg), female 55 ± 20 kg (35-75 kg)
• expected survival time ≥3 months
• Voluntary written informed consent prior to trail screening

Exclusion Criteria:

• Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures
• Patients with prolonged QTc interval (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and coronary heart disease with symptoms requiring drug treatment
• B-ultrasound showed that the width of the fluid dark area in the pericardial cavity was ≥ 10 mm at the end of diastolic period
• Patients with previous or planned organ transplantation
• Patients receiving symptomatic treatment for early myelotoxicity within 7 days before enrollment
• HBV nucleic acid quantitation > 103 IU / ml
• Patients with active bleeding
• Patients with thrombosis, embolism, cerebral hemorrhage, cerebral infarction and other this kind of diseases or medical history
• Patients with active infection or persistent fever within 14 days before enrollment
• less than 6 weeks after major organ surgery
• Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT / AST > 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST > 5 times of upper limit of normal value for patients with liver metastasis ], abnormal renal function (serum creatinine > 1.5 times of upper limit of normal value)
• Mental disorders/Those who cannot obtain informed consent
• Patients with drug abuse and long-term alcohol abuse that affect evaluation
• The investigator determined not suitable to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tucidinostat Group; Chidamide Specification: 5mg / tablet. Dosage: oral, 20 mg (4 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)	Drug: Tucidinostat; Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.); Other Names: Chidamide，CS055，HBI-8000

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival（by IWC）	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	12months

Collaborators and Investigators

• Sponsor: Ou Bai, MD/PHD

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: DLBCL with HBV infection
• 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
• Other Study ID Numbers: CDB0369

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