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

NCT04661943 | Completed Phase 2

• 1 other identifier: CDB0369
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL with HBV infection

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival（by IWC）

  6months

Secondary Outcomes (1)

• Overall survival

  12months

Study Arms (1)

Tucidinostat Group

EXPERIMENTAL

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

Interventions

Tucidinostat DRUG

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.)

Also known as: Chidamide，CS055，HBI-8000

Tucidinostat Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ou Bai, MD/PHD: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: June 1, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)