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

Sponsor
oubai (Other)
Overall Status
Recruiting
CT.gov ID
NCT04661943
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma
Actual Study Start Date :
Nov 30, 2020
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [6months]

      Progression-free survival（by IWC）

    Secondary Outcome Measures

    1. Overall survival [12months]

      Overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Bethune Hospital of Jilin University Changchun Jilin China 130021

    Sponsors and Collaborators

    • oubai

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    oubai, M.D., The First Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT04661943
    Other Study ID Numbers:
    • CDB0369
    First Posted:
    Dec 10, 2020
    Last Update Posted:
    Dec 10, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Dec 10, 2020