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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: Tucidinostat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Chidamide 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.) | Drug: Tucidinostat<br>* 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.)<br>* Other names: Chidamide，CS055，HBI-8000;|

What is the study measuring?
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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 |