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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tucidinostat
Sponsored by
oubai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Bethune Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.)

Outcomes

Primary Outcome Measures

Progression-free survival
Progression-free survival（by IWC）

Secondary Outcome Measures

Overall survival
Overall survival

Full Information

First Posted
December 4, 2020
Last Updated
December 4, 2020
Sponsor
oubai
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1. Study Identification

Unique Protocol Identification Number
NCT04661943
Brief Title
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Official Title
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
oubai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
Tucidinostat
Other Intervention Name(s)
Chidamide，CS055，HBI-8000
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival（by IWC）
Time Frame
6months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou BAI, doctor
Phone
13039046656
Email
oubai16@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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